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Phase III Randomized Study of Acupressure for Chemotherapy-Induced Nausea in Women With Breast Cancer Receiving One of Three Combination Therapy Regimens

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Supportive care

Completed

Adult

NCI

MDA-NUR01-396
NCI-0109, NCI-P02-0230, NCI-5950, 5950, NCT00046865

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.

Entry 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

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

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

Expected Enrollment

A total of 244 patients will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

Suzanne Dibble, DNSc, RN, PhD, Principal investigator
Ph: 415-476-5685; 800-888-8664

Registry Information

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

Trial Start Date		2002-10-07

Registered in ClinicalTrials.gov		NCT00046865

Date Submitted to PDQ		2002-07-10

Information Last Verified		2004-11-22

NCI Grant/Contract Number		R01-CA84014, U10-CA45809

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.