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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00046865 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Nausea and Vomiting |
Procedure: acupressure therapy Procedure: management of therapy complications Procedure: nausea and vomiting therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial |
Study Start Date: | October 2002 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer and receiving one of the following combination therapy regimens:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Florida | |
H. Lee Moffitt Cancer Center CCOP Research Base | |
Tampa, Florida, United States, 33612 | |
United States, Texas | |
University of Texas M.D. Anderson CCOP Research Base | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Suzanne L. Dibble, DNSc, RN, PhD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000257016, MDA-NUR01-396, NCI-0109, NCI-P02-0230, NCI-5950 |
Study First Received: | October 3, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00046865 |
Health Authority: | United States: Federal Government |
nausea and vomiting stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Skin Diseases |
Breast Neoplasms Nausea Breast Diseases |
Neoplasms Neoplasms by Site |