Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Primary Purpose
Breast Cancer, Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calorie restricted diet plus exercise
Weight management classes
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calorie restricted diet plus exercise
Weight management classes
Arm Description
See Intervention Description
See Intervention Description
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Full Information
NCT ID
NCT02940470
First Posted
October 18, 2016
Last Updated
August 1, 2018
Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02940470
Brief Title
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Official Title
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Obesity, Overweight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calorie restricted diet plus exercise
Arm Type
Experimental
Arm Description
See Intervention Description
Arm Title
Weight management classes
Arm Type
Active Comparator
Arm Description
See Intervention Description
Intervention Type
Other
Intervention Name(s)
Calorie restricted diet plus exercise
Intervention Description
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Weight management classes
Intervention Description
Weekly 1-hour weight management classes for 12 weeks.
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
0, 6, 12, 18 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Raatz, PhD, MPH, RD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mindy S Kurzer, PhD, MPH, RD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28702218
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. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48.
Results Reference
derived
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Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
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