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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA155435-01 | U.S. NIH Grant/Contract | View source |
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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 intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + lifestyle intervention | Active Comparator |
| |
| Placebo + lifestyle intervention | Active Comparator |
| |
| Metformin + standard dietary guidelines | Active Comparator |
| |
| Placebo + standard dietary guidelines | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin | Insulin measured as percent change from baseline | change from baseline to 6 months |
| Glucose | Glucose measured as percent change from baseline | change from baseline to 6 months |
| C-reactive Protein | C-reactive protein measured as percent change from baseline | change from baseline to 6 months |
| Bioavailable Testosterone | Bioavailable testosterone measured as percent change from baseline | change from baseline to 6 months |
| Serum Hormone Binding Globulin | Serum hormone binding globulin measured as percent change from baseline | change from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36581893 | Derived | 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. | |
| 34920739 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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) |
| FG003 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin | Insulin measured as percent change from baseline | Obese or overweight postmenopausal breast cancer survivors | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | change from baseline to 6 months |
|
Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin vs Placebo | Main effect for Metformin vs Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury due to fall | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Patterson | University of San Diego, California | 8585349235 | repatterson@ucsd.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D002241 |
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Main effects of the factorial design were the planned primary analysis and what the study was powered on.
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| Placebo | Drug | 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 | Behavioral | Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss. |
|
| Standard printed dietary guidelines | Behavioral | Set of standard health education materials provided to participants at single time point (immediately after randomization) |
|
| 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. |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Time Since Diagnosis | Mean | Standard Deviation | years |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| OG002 | 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) |
| OG003 | 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) |
|
|
| Primary | Glucose | Glucose measured as percent change from baseline | Obese or overweight postmenopausal breast cancer survivors | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | change from baseline to 6 months |
|
|
|
| Primary | C-reactive Protein | C-reactive protein measured as percent change from baseline | Obese or overweight postmenopausal breast cancer survivors | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | change from baseline to 6 months |
|
|
|
| Primary | Bioavailable Testosterone | Bioavailable testosterone measured as percent change from baseline | Obese or overweight postmenopausal breast cancer survivors | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | change from baseline to 6 months |
|
|
|
| Primary | Serum Hormone Binding Globulin | Serum hormone binding globulin measured as percent change from baseline | Obese or overweight postmenopausal breast cancer survivors | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | change from baseline to 6 months |
|
|
|
|
| 5 |
| 333 |
| 1 |
| 333 |
| EG001 | Lifestyle vs. Control | Main effect for the lifestyle intervention vs control intervention | 5 | 333 | 1 | 333 |
| Abdominal pain | General disorders |
|
| slurred speach | General disorders |
|
| transient neurological defect | General disorders |
|
| transient ischemic attack | Cardiac disorders |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Carbohydrates |