NCT02940470

Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: USDA Grand Forks Human Nutrition Research Center · Federal
• Sex: Female
• Age: 44 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Obesity
• Overweight

Interventions

Type	Name	Description
OTHER	Calorie restricted diet plus exercise	Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
OTHER	Weight management classes	Weekly 1-hour weight management classes for 12 weeks.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• Completion: 2010-08-01
• First posted: 2016-10-21
• Last updated: 2018-08-03

Locations

1 site across 1 country: United States