Breast Cancer, Obesity, Overweight
Conditions
Brief summary
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
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
Interventions
OTHERCalorie restricted diet plus exercise
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
OTHERWeight management classes
Weekly 1-hour weight management classes for 12 weeks.
Sponsors
National Cancer Institute (NCI)
USDA Grand Forks Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
44 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | 0, 6, 12, 18 weeks |
Countries
United States
Outcome results
None listed