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Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

Primary Purpose

Breast Cancer, Drug-induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acupressure therapy
management of therapy complications
nausea and vomiting therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of breast cancer and receiving one of the following combination therapy regimens: Doxorubicin and cyclophosphamide with or without fluorouracil Doxorubicin with paclitaxel or docetaxel Fluorouracil, epirubicin, and cyclophosphamide Must be beginning second or third course of chemotherapy Nausea intensity with prior chemotherapy of at least 3 (moderate) on the intensity scale of the Morrow Assessment of Nausea and Emesis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Adult Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Concurrent antiemetics allowed

Sites / Locations

  • H. Lee Moffitt Cancer Center CCOP Research Base
  • University of Texas M.D. Anderson CCOP Research Base

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

Acupressure

Placebo Acupressure

Usual Care

Arm Description

Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.

Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.

Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2002
Last Updated
November 12, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00046865
Brief Title
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
Official Title
Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2002 (Actual)
Primary Completion Date
March 23, 2006 (Actual)
Study Completion Date
March 23, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.
Detailed Description
OBJECTIVES: Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone. Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms. Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes. Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site. Arm III: Patients receive usual nausea care during the second or third course of chemotherapy. All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Drug-induced Nausea and Vomiting
Keywords
nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
Arm Title
Placebo Acupressure
Arm Type
Placebo Comparator
Arm Description
Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
Intervention Type
Procedure
Intervention Name(s)
acupressure therapy
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
nausea and vomiting therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of breast cancer and receiving one of the following combination therapy regimens: Doxorubicin and cyclophosphamide with or without fluorouracil Doxorubicin with paclitaxel or docetaxel Fluorouracil, epirubicin, and cyclophosphamide Must be beginning second or third course of chemotherapy Nausea intensity with prior chemotherapy of at least 3 (moderate) on the intensity scale of the Morrow Assessment of Nausea and Emesis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Adult Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Concurrent antiemetics allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne L. Dibble, DNSc, RN, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center CCOP Research Base
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Texas M.D. Anderson CCOP Research Base
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

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