Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

57

Study ID:

NCT00046865

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There are 2 Locations for this study

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H. Lee Moffitt Cancer Center CCOP Research Base
Tampa Florida, 33612, United States
University of Texas M.D. Anderson CCOP Research Base
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

57

Study ID:

NCT00046865

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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