Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | December 2016 |
Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
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.
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.
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
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