Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care | Completed | Adult | NCI | MDA-NUR01-396 NCI-0109, NCI-P02-0230, NCI-5950, 5950, NCT00046865 |
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.
Entry 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
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
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
Expected Enrollment
A total of 244 patients will be accrued for this study within 2 years.
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.
Trial Lead Organizations
University of Texas M.D. Anderson CCOP Research Base
 | | | |
| Suzanne Dibble, DNSc, RN, PhD, Principal investigator | |
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| Registry Information | ||
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| Official Title | Treatment of Chemotherapy-Induced Nausea with Acupressure: A Phase III Trial | |
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| Trial Start Date | 2002-10-07 | |
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| Registered in ClinicalTrials.gov | NCT00046865 | |
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| Date Submitted to PDQ | 2002-07-10 | |
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| Information Last Verified | 2004-11-22 | |
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| NCI Grant/Contract Number | R01-CA84014, U10-CA45809 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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