Clinical trial NCT02940470: Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Official title: Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Obesity
Overweight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-10-21
Enrollment: 22
Sex: FEMALE
Minimum age (years): 44
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: 0, 6, 12, 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Susan Raatz, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Mindy S Kurzer, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arikawa AY, Kaufman BC, Raatz SK, Kurzer MS. Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. Pilot Feasibility Stud. 2017 Jul 10;4:17. doi: 10.1186/s40814-017-0160-9. eCollection 2018.