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Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

Primary Purpose

Hematopoietic/Lymphoid Cancer, Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic/Lymphoid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Diagnosis of malignant disease

  • No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing regimen or anthracycline + cyclophosphamide [AC])

    • Cisplatin at a dose of ≥70mg/m^2, with or without other chemotherapy agent(s) OR
    • Anthracycline (60 mg/m^2) plus cyclophosphamide(600 mg/m^2)
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

  • Required Initial Laboratory Values ≤ 120 days prior to registration

    • Serum Creatinine ≤2.0 mg/dL
    • Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN)
    • Absolute neutrophil count (ANC) ≥1500/mm^3
  • No nausea or vomiting ≤ 24 hours prior to registration
  • Negative pregnancy test (serum or urine) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion)
  • No severe cognitive compromise
  • No known history of CNS disease (e.g. brain metastases, seizure disorder)
  • No treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned during protocol therapy
  • No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy)
  • No concurrent use of amifostine
  • No concurrent abdominal radiotherapy
  • No concurrent use of quinolone antibiotic therapy
  • No chronic alcoholism (as determined by the investigator)
  • No known hypersensitivity to olanzapine
  • No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
  • No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic agent)

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Anchorage Radiation Therapy Center
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Regional Hospital
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Epic Care-Dublin
  • Bay Area Breast Surgeons Inc
  • Epic Care Partners in Cancer Care
  • UC San Diego Moores Cancer Center
  • Contra Costa Regional Medical Center
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Tumor Institute
  • Hematology and Oncology Associates-Oakland
  • Saint Mary Corwin Medical Center
  • Rocky Mountain Cancer Centers-Aurora
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Rocky Mountain Cancer Centers-Boulder
  • Penrose-Saint Francis Healthcare
  • Rocky Mountain Cancer Centers-Penrose
  • Porter Adventist Hospital
  • Exempla Saint Joseph Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rocky Mountain Cancer Centers-Midtown
  • Rocky Mountain Cancer Centers-Rose
  • Rose Medical Center
  • Colorado Blood Cancer Institute
  • Mercy Medical Center
  • Southwest Oncology PC
  • Comprehensive Cancer Care and Research Institute of Colorado LLC
  • Swedish Medical Center
  • Mountain Blue Cancer Care Center
  • North Colorado Medical Center
  • Rocky Mountain Cancer Centers-Greenwood Village
  • Rocky Mountain Cancer Centers-Lakewood
  • Saint Anthony Hospital
  • Rocky Mountain Cancer Centers-Littleton
  • Littleton Adventist Hospital
  • Rocky Mountain Cancer Centers-Sky Ridge
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • Rocky Mountain Cancer Centers-Longmont
  • McKee Medical Center
  • Parker Adventist Hospital
  • Rocky Mountain Cancer Centers-Parker
  • Rocky Mountain Cancer Centers - Pueblo
  • Rocky Mountain Cancer Centers-Thornton
  • Exempla Lutheran Medical Center
  • Saint Francis Hospital and Medical Center
  • Beebe Medical Center
  • Christiana Gynecologic Oncology LLC
  • Delaware Clinical and Laboratory Physicians PA
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Regional Hematology and Oncology PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • Nanticoke Memorial Hospital
  • Christiana Care Health System-Wilmington Hospital
  • MedStar Georgetown University Hospital
  • MedStar Washington Hospital Center
  • Florida Hospital Memorial Medical Center
  • Phoebe Putney Memorial Hospital
  • Oncare Hawaii Inc-Pali Momi
  • Pali Momi Medical Center
  • The Cancer Center of Hawaii-Leeward
  • Oncare Hawaii Inc-POB II
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Kuakini Medical Center
  • Oncare Hawaii Inc-Kuakini
  • OnCare Hawaii-Liliha
  • The Cancer Center of Hawaii-Liliha
  • Kapiolani Medical Center for Women and Children
  • Tripler Army Medical Center
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Luke's Mountain States Tumor Institute
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Saint Joseph Medical Center
  • Memorial Hospital of Carbondale
  • Cancer Care Specialists of Central Illinois
  • Decatur Memorial Hospital
  • Advocate Sherman Hospital
  • Illinois CancerCare Galesburg
  • Western Illinois Cancer Treatment Center
  • Ingalls Memorial Hospital
  • Good Samaritan Regional Health Center
  • Oconomowoc Memorial Hospital-ProHealth Care Inc
  • Methodist Medical Center of Illinois
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Medical Center
  • Valley Radiation Oncology
  • OSF Saint Anthony Medical Center
  • Southern Illinois University School of Medicine
  • Memorial Medical Center
  • Waukesha Memorial Hospital
  • Memorial Regional Cancer Center Day Road
  • Memorial Hospital of South Bend
  • Mary Greeley Medical Center
  • McFarland Clinic PC-William R Bliss Cancer Center
  • McFarland Clinic PC-Boone
  • Physicians' Clinic of Iowa PC
  • Oncology Associates at Mercy Medical Center
  • Mercy Hospital
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Iowa Lutheran Hospital
  • Mercy Medical Center-Sioux City
  • McFarland Clinic PC-Trinity Cancer Center
  • McFarland Clinic PC-Jefferson
  • McFarland Clinic PC-Marshalltown
  • Mercy Medical Center - North Iowa
  • Siouxland Regional Cancer Center
  • Saint Luke's Regional Medical Center
  • Methodist West Hospital
  • Baptist Health Corbin
  • Hardin Memorial Hospital
  • Baptist Health Lexington
  • Newton-Wellesley Hospital
  • Botsford Hospital
  • William Beaumont Hospital - Troy
  • Mercy Hospital-Joplin
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Phelps County Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Southeastern Medical Oncology Center-Clinton
  • Southeastern Medical Oncology Center-Goldsboro
  • Wayne Memorial Hospital
  • Southeastern Medical Oncology Center-Jacksonville
  • Southeastern Medical Oncology Center-Wilson
  • Dayton NCI Community Oncology Research Program
  • Rhode Island Hospital
  • Miriam Hospital
  • Central Vermont Medical Center
  • University of Vermont College of Medicine
  • Providence Regional Cancer System-Yelm
  • Edwards Comprehensive Cancer Center
  • Cheyenne Regional Medical Center-West
  • Marshfield Clinic-Chippewa Center
  • Marshfield Clinic Cancer Center at Sacred Heart
  • Saint Agnes Hospital/Agnesian Cancer Center
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • Saint Mary's Hospital
  • Gundersen Lutheran Medical Center
  • Holy Family Memorial Hospital
  • Bay Area Medical Center
  • Marshfield Clinic
  • Froedtert and the Medical College of Wisconsin
  • Marshfield Clinic-Minocqua Center
  • D N Greenwald Center
  • Westfields Hospital/Cancer Center of Western Wisconsin
  • Green Bay Oncology - Oconto Falls
  • Marshfield Clinic at James Beck Cancer Center
  • Lakeview Medical Center-Marshfield Clinic
  • Marshfield Clinic-Rice Lake Center
  • William Beaumont Hospital-Royal Oak
  • Saint Nicholas Hospital
  • Marshfield Clinic Cancer Care at Saint Michael's Hospital
  • Green Bay Oncology - Sturgeon Bay
  • Marshfield Clinic-Wausau Center
  • Marshfield Clinic - Weston Center
  • Marshfield Clinic - Wisconsin Rapids Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olanzapine + Chemotherapy + Antiemetic treatment

Placebo + Chemotherapy + Antiemetic treatment

Arm Description

Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)

Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus placebo

Outcomes

Primary Outcome Measures

Proportion of Patients With no Nausea
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.

Secondary Outcome Measures

Median Nausea Scores
Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Proportion of Patients With Complete Response
Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Frequency of Rescue Medication
Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.

Full Information

First Posted
April 15, 2014
Last Updated
April 28, 2020
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02116530
Brief Title
Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
Official Title
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
Detailed Description
Patients with cancer may receive chemotherapy that may cause nausea and vomiting. The purpose of this study is to determine if the use of olanzapine in combination with antiemetic therapy can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. Patients are randomized to one of two treatment arms. Please see the "Arms and Intervention" sections for more detailed information. The primary objective is to compare the number of patients with no nausea for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) and overall periods (0-120 hours post-chemotherapy) for patients receiving HEC. The secondary objectives are: To compare the complete response (CR) (no emetic episodes and no use of rescue medication) in the acute, delayed and overall periods To compare the incidences of potential toxicities ascribed to olanzapine Protocol treatment is to begin ≤ 14 days of registration. Patients will receive treatment on Days 1-4. Patients will be permitted to take rescue therapy of the treating investigator's choice for nausea and/or emesis/retching, based on clinical circumstances. After completing treatment, patients will be monitored for side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic/Lymphoid Cancer, Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine + Chemotherapy + Antiemetic treatment
Arm Type
Experimental
Arm Description
Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
Arm Title
Placebo + Chemotherapy + Antiemetic treatment
Arm Type
Active Comparator
Arm Description
Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus placebo
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Intervention Description
oral or IV
Intervention Type
Drug
Intervention Name(s)
Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Intervention Description
oral or IV
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Proportion of Patients With no Nausea
Description
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
Time Frame
0 to 120 hours after chemotherapy
Secondary Outcome Measure Information:
Title
Median Nausea Scores
Description
Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Time Frame
Baseline and Day 2 to Day 6 after chemotherapy
Title
Proportion of Patients With Complete Response
Description
Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Time Frame
0 to 120 hours after chemotherapy
Title
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Description
Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Time Frame
Baseline and day 2 to 6 days after chemotherapy
Title
Frequency of Rescue Medication
Description
Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.
Time Frame
Day 2 to Day 6 after chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of malignant disease No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing regimen or anthracycline + cyclophosphamide [AC]) Cisplatin at a dose of ≥70mg/m^2, with or without other chemotherapy agent(s) OR Anthracycline (60 mg/m^2) plus cyclophosphamide(600 mg/m^2) Age ≥18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 Required Initial Laboratory Values ≤ 120 days prior to registration Serum Creatinine ≤2.0 mg/dL Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN) Absolute neutrophil count (ANC) ≥1500/mm^3 No nausea or vomiting ≤ 24 hours prior to registration Negative pregnancy test (serum or urine) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion) No severe cognitive compromise No known history of CNS disease (e.g. brain metastases, seizure disorder) No treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned during protocol therapy No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy) No concurrent use of amifostine No concurrent abdominal radiotherapy No concurrent use of quinolone antibiotic therapy No chronic alcoholism (as determined by the investigator) No known hypersensitivity to olanzapine No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic agent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolph M. Navari, MD, PhD, FACP
Organizational Affiliation
Indiana University School of Medicine South Bend
Official's Role
Study Chair
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Anchorage Radiation Therapy Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99504
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Regional Hospital
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Epic Care-Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
Bay Area Breast Surgeons Inc
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Facility Name
Epic Care Partners in Cancer Care
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
945553
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Hematology and Oncology Associates-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
California
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80901
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Penrose
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Exempla Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Mercy Medical Center
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Southwest Oncology PC
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Comprehensive Cancer Care and Research Institute of Colorado LLC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Mountain Blue Cancer Care Center
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Greenwood Village
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Lakewood
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Sky Ridge
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Parker
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Pueblo
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Gynecologic Oncology LLC
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Regional Hematology and Oncology PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
Nanticoke Memorial Hospital
City
Sanford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Christiana Care Health System-Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Hospital Memorial Medical Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Phoebe Putney Memorial Hospital
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Oncare Hawaii Inc-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
The Cancer Center of Hawaii-Leeward
City
'Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Oncare Hawaii Inc-POB II
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Oncare Hawaii Inc-Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
OnCare Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute-Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Memorial Hospital of Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62902
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Advocate Sherman Hospital
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
Illinois CancerCare Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Oconomowoc Memorial Hospital-ProHealth Care Inc
City
Oconomowoc
State/Province
Illinois
ZIP/Postal Code
53066
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Valley Radiation Oncology
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
OSF Saint Anthony Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Illinois
ZIP/Postal Code
53188
Country
United States
Facility Name
Memorial Regional Cancer Center Day Road
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Mary Greeley Medical Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic PC-William R Bliss Cancer Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
McFarland Clinic PC-Boone
City
Boone
State/Province
Iowa
ZIP/Postal Code
50036
Country
United States
Facility Name
Physicians' Clinic of Iowa PC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
51102
Country
United States
Facility Name
McFarland Clinic PC-Trinity Cancer Center
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Facility Name
McFarland Clinic PC-Jefferson
City
Jefferson
State/Province
Iowa
ZIP/Postal Code
50129
Country
United States
Facility Name
McFarland Clinic PC-Marshalltown
City
Marshalltown
State/Province
Iowa
ZIP/Postal Code
50158
Country
United States
Facility Name
Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Baptist Health Corbin
City
Corbin
State/Province
Kentucky
ZIP/Postal Code
40701
Country
United States
Facility Name
Hardin Memorial Hospital
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Botsford Hospital
City
Farmington
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
William Beaumont Hospital - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mercy Hospital-Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Phelps County Regional Medical Center
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Southeastern Medical Oncology Center-Clinton
City
Clinton
State/Province
North Carolina
ZIP/Postal Code
28328
Country
United States
Facility Name
Southeastern Medical Oncology Center-Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Memorial Hospital
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Southeastern Medical Oncology Center-Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Southeastern Medical Oncology Center-Wilson
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Dayton NCI Community Oncology Research Program
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Central Vermont Medical Center
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Cheyenne Regional Medical Center-West
City
Cheyenne
State/Province
Wisconsin
ZIP/Postal Code
82001
Country
United States
Facility Name
Marshfield Clinic-Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Clinic Cancer Center at Sacred Heart
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Saint Agnes Hospital/Agnesian Cancer Center
City
Fond Du Lac
State/Province
Wisconsin
ZIP/Postal Code
54935
Country
United States
Facility Name
Green Bay Oncology at Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology Limited at Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Holy Family Memorial Hospital
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Facility Name
Westfields Hospital/Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Facility Name
Green Bay Oncology - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Marshfield Clinic at James Beck Cancer Center
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
Lakeview Medical Center-Marshfield Clinic
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Marshfield Clinic-Rice Lake Center
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Wisconsin
ZIP/Postal Code
48073
Country
United States
Facility Name
Saint Nicholas Hospital
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Marshfield Clinic Cancer Care at Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Green Bay Oncology - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Marshfield Clinic - Weston Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27410922
Citation
Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.
Results Reference
derived
Links:
URL
https://nctn-data-archive.nci.nih.gov/
Description
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

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