Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
NCT ID: NCT01302379
Last Updated: 2020-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
333 participants
INTERVENTIONAL
2011-08-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Metformin + lifestyle intervention
Metformin
Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Placebo + lifestyle intervention
Placebo
Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Metformin + standard dietary guidelines
Metformin
Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)
Placebo + standard dietary guidelines
Placebo
Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)
Interventions
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Metformin
Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Placebo
Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Stage I, II, or III breast cancer within past 5 years
* Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
* Not scheduled for or currently undergoing chemotherapy
* Accessible geographically and by telephone
* Able to communicate dietary and physical activity data via telephone
* If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
* Post-menopausal at diagnosis
Exclusion Criteria
* Evidence of renal insufficiency, liver disease, or congestive heart failure
* Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
* Recent initiation (\< 3 months ago) of thiazides or β-blockers
* Taking insulin or other antidiabetic drug
* Other primary or recurrent invasive cancer in past 10 years
* Unable to commit to study requirements
FEMALE
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Ruth E. Patterson
Professor, Department of Family & Preventive Medicine
Locations
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Moores UCSD Cancer Center
La Jolla, California, United States
Countries
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References
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Bellerba F, Chatziioannou AC, Jasbi P, Robinot N, Keski-Rahkonen P, Trolat A, Vozar B, Hartman SJ, Scalbert A, Bonanni B, Johansson H, Sears DD, Gandini S. Metabolomic profiles of metformin in breast cancer survivors: a pooled analysis of plasmas from two randomized placebo-controlled trials. J Transl Med. 2022 Dec 29;20(1):629. doi: 10.1186/s12967-022-03809-6.
Nwanaji-Enwerem JC, Chung FF, Van der Laan L, Novoloaca A, Cuenin C, Johansson H, Bonanni B, Hubbard AE, Smith MT, Hartman SJ, Cardenas A, Sears DD, Herceg Z. An epigenetic aging analysis of randomized metformin and weight loss interventions in overweight postmenopausal breast cancer survivors. Clin Epigenetics. 2021 Dec 17;13(1):224. doi: 10.1186/s13148-021-01218-y.
Other Identifiers
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U54 CA155435-01 Project 3
Identifier Type: -
Identifier Source: org_study_id
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