Trial Information

Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial

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.