Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
Overview[ - collapse ][ - ]
| Purpose | This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months. |
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| Condition | Breast Neoplasms |
| Intervention | Drug: Metformin Drug: Placebo Behavioral: Lifestyle intervention Behavioral: Standard printed dietary guidelines |
| Phase | N/A |
| Sponsor | University of California, San Diego |
| Responsible Party | University of California, San Diego |
| ClinicalTrials.gov Identifier | NCT01302379 |
| First Received | February 23, 2011 |
| Last Updated | August 27, 2012 |
| Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 23, 2011 |
|---|---|
| Last Updated Date | August 27, 2012 |
| Start Date | August 2011 |
| Estimated Primary Completion Date | July 2016 |
| Current Primary Outcome Measures | Biological markers associated with breast cancer survival [Time Frame: Baseline, 6 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors |
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| Official Title | Obesity-related Mechanisms and Mortality in Breast Cancer Survivors |
| Brief Summary | This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition | Breast Neoplasms |
| Intervention | Drug: 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 Drug: 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 Other Names: Sugar pillBehavioral: Lifestyle intervention Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss. Behavioral: Standard printed dietary guidelines Set of standard health education materials provided to participants at single time point (immediately after randomization) |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 340 |
| Estimated Completion Date | July 2016 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion Criteria: - BMI at least 25.0 kg/m2 - 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: - Preliminary bloodwork outside of specified ranges - 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 |
| Gender | Female |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Jesica Oratowski Coleman 8588223311 joratowski@ucsd.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01302379 |
|---|---|
| Other Study ID Numbers | U54 CA155435-01 Project 3 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of California, San Diego |
| Study Sponsor | University of California, San Diego |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2012 |
Locations[ + expand ][ + ]
| Moores UCSD Cancer Center | La Jolla, California, United States, 92093 Principal Investigator: Ruth E Patterson, PhDRecruiting |
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