Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
3 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedAugust 3, 2018
August 1, 2018
1 year
October 18, 2016
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in body weight
0, 6, 12, 18 weeks
Study Arms (2)
Calorie restricted diet plus exercise
EXPERIMENTALSee Intervention Description
Weight management classes
ACTIVE COMPARATORSee Intervention Description
Interventions
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
Weekly 1-hour weight management classes for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
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.
PMID: 28702218DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Raatz, PhD, MPH, RD
USDA Grand Forks Human Nutrition Research Center
- PRINCIPAL INVESTIGATOR
Mindy S Kurzer, PhD, MPH, RD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 21, 2016
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
August 1, 2010
Last Updated
August 3, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share