- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046865
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center CCOP Research Base
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas M.D. Anderson CCOP Research Base
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupressure
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.
|
|
Placebo Comparator: Placebo Acupressure
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.
|
|
Sham Comparator: Usual Care
Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne L. Dibble, DNSc, RN, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000257016
- MDA-NUR01-396
- NCI-0109
- NCI-P02-0230
- NCI-5950
- NUR01-396 (Other Identifier: UT MD Andrerson Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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