Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors



Status:Completed
Conditions:Breast Cancer, Cancer, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:44 - 75
Updated:8/5/2018
Start Date:January 2009
End Date:August 2010

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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.

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

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
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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