Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
- 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
- Arm III: Patients receive usual nausea care during the second or third course of
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Suzanne L. Dibble, DNSc, RN, PhD
University of California, San Francisco
United States: Institutional Review Board
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|
|H. Lee Moffitt Cancer Center CCOP Research Base||Tampa, Florida 33612|