Breast Cancer Clinical Trial

Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

333

Study ID:

NCT01302379

Recruitment Status:

Completed

Sponsor:

University of California, San Diego

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There is 1 Location for this study

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Moores UCSD Cancer Center
La Jolla California, 92093, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

333

Study ID:

NCT01302379

Recruitment Status:

Completed

Sponsor:


University of California, San Diego

How clear is this clinincal trial information?

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