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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046865
• Other study ID #: CDR0000257016
• Secondary ID: MDA-NUR01-396NCI
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2002
• Est. completion date: March 23, 2006

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 23, 2006
• Est. primary completion date: March 23, 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Drug-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Procedure:
• acupressure therapy

• management of therapy complications

• nausea and vomiting therapy

Locations

Country	Name	City	State
United States	University of Texas M.D. Anderson CCOP Research Base	Houston	Texas
United States	H. Lee Moffitt Cancer Center CCOP Research Base	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,