Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

Study Overview
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Brief Summary
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The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.

Detailed Description
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Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued: To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence To assess the impact of the weight loss interventions on quality of life and sleep To assess the impact of weight loss on measures of bone health

Official Title
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Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

Conditions
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Breast Cancer, Obesity, Overweight

Intervention / Treatment
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* Other: Calorie restricted diet plus exercise
* Other: Weight management classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal (defined as experiencing at least 12 months without a menstrual period) diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment BMI ≥ 27 kg/m2 less than 7 servings of alcohol per week willing to be randomized into either group not planning to move away from the area during the period of study non-smoker Exclusion Criteria: serious illness requiring medical treatment inability to participate in physical activity due to severe disability history of schizophrenia, psychosis or untreated major depression unwilling to commute to study site once per week failure to provide written informed consent

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie restricted diet plus exercise<br>See Intervention Description | Other: Calorie restricted diet plus exercise<br>* Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.<br>|
| Active Comparator: Weight management classes<br>See Intervention Description | Other: Weight management classes<br>* Weekly 1-hour weight management classes for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 0, 6, 12, 18 weeks |