Breast Cancer, Drug-induced Nausea and Vomiting
Conditions
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
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.
Interventions
PROCEDUREacupressure therapy
PROCEDUREmanagement of therapy complications
PROCEDUREnausea and vomiting therapy
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed