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UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (IRB 2003-551)

Primary Purpose

Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ginger extract
placebo
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea and Vomiting focused on measuring nausea and vomiting, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of cancer Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute) Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only) Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria: Agent is the same that is scheduled for the next round of chemotherapy Experienced nausea and/or vomiting of any severity (delayed or acute) Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic No history of bleeding disorder No thrombocytopenia Hepatic Not specified Renal Not specified Gastrointestinal Able to swallow capsules No gastric ulcer No clinical evidence of current or impending bowel obstruction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to understand English Able to complete study questionnaires No allergy to ginger PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior chemotherapy regimens with multiple day doses Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas: Total body irradiation Hemi-body Upper abdomen Abdominal-pelvic mantle Cranium (radiosurgery) Craniospinal radiotherapy Surgery Not specified Other More than 1 week since prior ginger (teas, capsules, tinctures) No other concurrent ginger (teas, capsules, tinctures) Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed No concurrent therapeutic-doses of warfarin, aspirin, or heparin Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

Sites / Locations

  • CCOP - Northern Indiana CR Consortium
  • University of Michigan Cancer Center CCOP Research Base
  • University of Michigan Comprehensive Cancer Center
  • CCOP - Grand Rapids
  • MBCCOP - Our Lady of Mercy Cancer Center
  • MBCCOP - San Juan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm III

Arm Description

Patients receive lower-dose oral ginger twice daily.

Patients receive higher-dose oral ginger twice daily.

Patients receive oral placebo twice daily.

Outcomes

Primary Outcome Measures

Most efficacious dose
Safety
Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
October 20, 2016
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00064272
Brief Title
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Acronym
IRB 2003-551
Official Title
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer. PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.
Detailed Description
OBJECTIVES: Primary Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo. Secondary Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens. Compare the safety of these regimens in these patients. Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting). OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist). Arm I: Patients receive lower-dose oral ginger twice daily. Arm II: Patients receive higher-dose oral ginger twice daily. Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days. Patients are followed at 1 week. PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
nausea and vomiting, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive lower-dose oral ginger twice daily.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive higher-dose oral ginger twice daily.
Arm Title
Arm III
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo twice daily.
Intervention Type
Drug
Intervention Name(s)
ginger extract
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Most efficacious dose
Title
Safety
Title
Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of cancer Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute) Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only) Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria: Agent is the same that is scheduled for the next round of chemotherapy Experienced nausea and/or vomiting of any severity (delayed or acute) Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic No history of bleeding disorder No thrombocytopenia Hepatic Not specified Renal Not specified Gastrointestinal Able to swallow capsules No gastric ulcer No clinical evidence of current or impending bowel obstruction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to understand English Able to complete study questionnaires No allergy to ginger PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior chemotherapy regimens with multiple day doses Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas: Total body irradiation Hemi-body Upper abdomen Abdominal-pelvic mantle Cranium (radiosurgery) Craniospinal radiotherapy Surgery Not specified Other More than 1 week since prior ginger (teas, capsules, tinctures) No other concurrent ginger (teas, capsules, tinctures) Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed No concurrent therapeutic-doses of warfarin, aspirin, or heparin Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanna Zick, MPH, ND
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
University of Michigan Cancer Center CCOP Research Base
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0725
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
MBCCOP - Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

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UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

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