The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors.

Condition	Intervention
Breast Cancer	Behavior: weight loss counseling

Further Study Details: 

Primary Outcomes: weight loss
Secondary Outcomes: markers of oxidative stress in blood and breast fluid; markers of cardiovascular health in blood; body fat; fitness
Expected Total Enrollment:  100

Obesity has adverse effects on breast cancer survival and recurrence, and this may be mediated via the insulin resistance that is associated with obesity. This is a matter of exceptional concern for African-American (AA) breast cancer survivors since a greater proportion of AAs than European Americans (EA) are obese, insulin-resistant and diabetic. This proposal seeks to test the effects of weight loss intervention in obese and overweight AA breast cancer survivors (body mass index 25-40 kg/m2, stage I, II, or IIIA cancer, free of recurrence). Subjects (n=100) will be randomized across 3 arms: 1) control; 2) individualized, dietitian-led counseling; and 3) dietitian-led counseling combined with peer counseling using telephone counseling by trained peers who are AA breast cancer survivors successful at weight control. Psychosocial factors that can affect the extent of weight loss achieved will be assessed, including individual, home and community-level factors. Some of these factors may change when weight loss is achieved and will be assessed both before and after intervention. Genetic polymorphisms that have been shown to be associated with increased body weight, insulin resistance, lipid metabolism, and oxidative stress will be determined and related to both baseline and post-intervention anthropometric and biologic measures. This should further help elucidate inter-individual differences in response to weight loss intervention. The possible beneficial effects of weight loss on the health risks associated with obesity will be evaluated with measures of insulin resistance, insulin-like growth factor and lipid levels in blood samples, as well as with blood pressure and anthropometric measures. The effects of weight loss on these measures have been studied in other obese and overweight populations, but there is little data in breast cancer survivors. Finally, we will attempt to determine if beneficial effects of weight loss can be detected in the breast, since this should be related to subsequent breast cancer risk. The breast contralateral to surgery will be subjected to ductal lavage at baseline, 12 and 24 months. The investigators will examine the effects of weight change on markers of oxidative stress in the breast nipple aspirate fluid that is obtained as part of the lavage procedure. Levels of lipid peroxidation are very high in this fluid and have been related to both nuclear atypia and breast cancer risk. The nuclear morphology of epithelial cells obtained by ductal lavage therefore will be quantified as well. Weight loss in obese and overweight AA breast cancer survivors should improve both psychosocial function and biological indicators of health risks.

Ages Eligible for Study:  18 Years   -   71 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Overweight or obese
• African American
• Up to 5 years post breast cancer diagnosis
• Able to keep food records
• Have a telephone
• Stable weight within 5 pounds last 2 months

Exclusion Criteria:

• Breast cancer recurrence
• History of other cancers
• Uncontrolled congestive heart failure
• Untreated hypertension
• Disabling osteoarthritis
• Abusing drugs or alcohol
• Have psychiatric conditions that interfere with counseling

Please refer to this study by ClinicalTrials.gov identifier  NCT00120029

Donna Ford, BS      313-745-5774    dford@med.wayne.edu

Michigan
      Wayne State University, Detroit,  Michigan,  48201,  United States; Recruiting

Study chairs or principal investigators

Zora Djuric, PhD,  Principal Investigator,  University of Michigan   

Study ID Numbers:  057103MP4F; 1P50 ES012395
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00120029
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26