Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors (NCT01302379) | Clinical Trial Compass
CompletedNot Applicable
Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
United States333 participantsStarted 2011-08
Plain-language 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 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.