Spots Global Cancer Trial Database for Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

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Trial Identification

Brief Title: Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

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

Study ID: NCT00046865

Conditions

Breast Cancer

Drug-induced Nausea and Vomiting

Interventions

acupressure therapy

management of therapy complications

nausea and vomiting therapy

Study Description

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.