Completed

NCT Number: NCT00046865

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Drug-induced Nausea and Vomiting Nausea Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

H. Lee Moffitt Cancer Center CCOP Research Base, Tampa, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupressure therapy

Procedure

management of therapy complications

Procedure

nausea and vomiting therapy

Procedure

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Jan 27, 2003
Registry last updated: Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed