|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068458 |
Purpose
RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.
PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.
| Condition | Intervention | Phase |
|
Breast Cancer Depression Quality of Life Weight Changes |
Procedure: management of therapy complications Procedure: quality-of-life assessment |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Depression Exercise and Physical Fitness |
| Study Type: | Interventional |
| Study Design: | Other, Randomized, Active Control |
| Official Title: | A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer |
| Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m^2 vs more than 25 kg/m^2), race (white vs non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms.
In all arms, patients continue regimens for 6 months.
Measurements of body composition, weight, waist circumference, serum levels of insulin, insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained at baseline and 6 months.
Quality of life, depression, diet composition, and physical activity are assessed at baseline and at 3 and 6 months.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study within 16 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal Status
Premenopausal, defined as at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, North Carolina | |||||
| Comprehensive Cancer Center at Wake Forest University | |||||
| Winston-Salem, North Carolina, United States, 27157-1030 | |||||
| Duke Comprehensive Cancer Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| Southeastern Medical Oncology Center | |||||
| Goldsboro, North Carolina, United States, 27534 | |||||
| United States, South Carolina | |||||
| Cancer Centers of the Carolinas - Eastside | |||||
| Greenville, South Carolina, United States, 29615 | |||||
| Wake Forest University |
| National Cancer Institute (NCI) |
| Study Chair: | Edward G. Shaw, MD | Wake Forest University |
| Investigator: | Wendy Demark-Wahnefried, PhD | Duke University |
| Investigator: | Roger T. Anderson, PhD | Wake Forest University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000322831, CCCWFU-97301, CCCWFU-BG02-196, CCCWFU-00-29(A) |
| First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068458 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|