Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
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.
OBJECTIVES:
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.
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.
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer and receiving one of the following combination therapy regimens:
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:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other