Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Overweight; Obesity; Breast Cancer
• Interventions: Other: Weight management classes; Other: Calorie restricted diet plus exercise

• Registration Number: NCT02940470
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-08
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight management classes	Weight management classes	See Intervention Description
Calorie restricted diet plus exercise	Calorie restricted diet plus exercise	See Intervention Description

Primary Outcome Measures

Name	Time	Method
Change in body weight	0, 6, 12, 18 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States