Lifestyle, Exercise and Nutrition (LEAN) Study 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Yale University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Change in body weight in kilograms (kg)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.
Detailed Description
We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
- •BMI \>25 kg/m2
- •Completed surgery, chemotherapy and radiation at least 2 months ago
- •Physically able to exercise
- •Agrees to be randomly assigned to either weight loss or control
- •Gives informed consent to participate in all study activities
- •Able to come for baseline and 6-month clinic visits
- •Mentally competent
Exclusion Criteria
- •Patients with double mastectomy
Outcomes
Primary Outcomes
Change in body weight in kilograms (kg)
Time Frame: 6 months
Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg. All measures will be performed and recorded twice in succession.
Change in Body Mass Index (BMI)
Time Frame: 6 months
BMI will be calculated using weight and height measurements (weight (kg)/height (m)\^2 ). Weight and height will be measured by research staff blinded to the participant's randomization group at baseline and 6-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured in a standard manner, without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. All measures will be performed and recorded twice in succession.
Change in breast tissue markers
Time Frame: 6 months
We will collect a breast tissue biopsy from the unaffected breast at baseline and 6 months. Six slides will be made from each specimen for immunohistochemistry, as follows: Ki67 (MIB-1, DAKO), IGF1 receptor (1D5; DAKO), insulin receptor (mouse anti-human monoclonal B1445; LifeSpan BioSciences), Estrogen receptor (SP1, NeoMarker), Progesterone receptor (pgR636, DAKO) and HER-2 neu (SP3, NeoMarker). Ki67 will be scored quantitatively (% positive nuclei) using the Aperio system (Specialized Histopathology Laboratory). Estrogen and progesterone receptors will be scored following current ASCO/CAP guidelines (percent positive, intensity). Her2 will be scored according to current ASCO/CAP guidelines (intensity of membrane staining). All other markers will be scored on a semi-quantitative scale (0 to 3+).
Change in percent body fat
Time Frame: 6 months
Dual Energy X-Ray Absorptiometry (DEXA) scans will be performed at baseline and 6-months. The DEXA measurements will be made with a Hologic scanner (Hologic 4500 with a "Discovery" upgrade, Hologic Inc, Waltham, Mass). A whole-body scan takes approximately 10 minutes to complete. We will measure percent body fat utilizing DEXA.
Secondary Outcomes
- Change in fasting insulin(6 months)
- Change in C-reactive protein(6 months)
- Maintenance of Weight Loss(12 months)
- Changes in salivary cortisol(6 months)
- Change in Leptin(6 months)
- Skin Carotenoids Assessment(6 months)