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Exercise and Dietary Counseling That Could Affect Weight Loss and Improve Quality of Life of Obese Patients With Stage I or Stage II Endometrial Cancer in Remission
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262938
  Purpose

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
Cancer-Related Problem/Condition
Endometrial Cancer
Procedure: behavioral dietary intervention
Procedure: counseling
Procedure: educational intervention
Procedure: preventative dietary intervention
Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Exercise and Physical Fitness Obesity Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Active Control
Official Title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months [ Designated as safety issue: No ]
  • Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months [ Designated as safety issue: No ]
  • Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) [ Designated as safety issue: No ]
  • Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months [ Designated as safety issue: No ]

Study Start Date: February 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission.

Secondary

  • Determine the feasibility and acceptability of lifestyle interventions in these patients.

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.

  • Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
  • Arm II: Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.

After completion of study treatment, patients are followed at 1 year.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial cancer meeting the following criteria:

    • Stage I or II disease
    • Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
    • Disease in remission
  • Body Mass Index (BMI) ≥ 25

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262938

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5047
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Vivian von Gruenigen, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
quality of life
stage I endometrial carcinoma
stage II endometrial carcinoma
weight changes

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009