Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940470
• Other study ID #: UMN999
• Secondary ID: U54CA116849CPRC#
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2018
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 44 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity
• Overweight
• Weight Loss

Intervention

Other:
• Calorie restricted diet plus exercise
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
• Weight management classes
Weekly 1-hour weight management classes for 12 weeks.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		0, 6, 12, 18 weeks