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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00262938 |
RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.
PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.
Condition | Intervention |
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Cancer-Related Problem/Condition Endometrial Cancer |
Procedure: behavioral dietary intervention Procedure: counseling Procedure: educational intervention Procedure: preventative dietary intervention Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Randomized, Active Control |
Official Title: | Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study. Patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial cancer meeting the following criteria:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Not specified
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5047 |
Study Chair: | Vivian von Gruenigen, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000450977, CASE-5804, CASE-020505 |
Study First Received: | December 6, 2005 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00262938 |
Health Authority: | United States: Federal Government |
quality of life stage I endometrial carcinoma stage II endometrial carcinoma weight changes |
Obesity Genital Neoplasms, Female Uterine Diseases Quality of Life Urogenital Neoplasms Carcinoma Body Weight |
Genital Diseases, Female Endometrial Neoplasms Weight Loss Body Weight Changes Uterine Neoplasms Endometrial cancer |
Neoplasms Neoplasms by Site |