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OpenTrials
Completed

NCT Number: NCT02940470

Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

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.

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Key information

Age range

44 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calorie restricted diet plus exercise

Other

Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.

Weight management classes

Other

Weekly 1-hour weight management classes for 12 weeks.

Primary outcomes

  1. Change in body weight

    Time frame: 0, 6, 12, 18 weeks

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2016
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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