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Completed

NCT Number: NCT01302379

Reach for Health Study: 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 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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Key information

Conditions

Breast Neoplasms Body Weight Body Weight Changes Breast Diseases Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Weight Loss

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: Sugar pill

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)

Primary outcomes

  1. Insulin

    Time frame: change from baseline to 6 months

    Insulin measured as percent change from baseline

  2. Glucose

    Time frame: change from baseline to 6 months

    Glucose measured as percent change from baseline

  3. C-reactive Protein

    Time frame: change from baseline to 6 months

    C-reactive protein measured as percent change from baseline

  4. Bioavailable Testosterone

    Time frame: change from baseline to 6 months

    Bioavailable testosterone measured as percent change from baseline

  5. Serum Hormone Binding Globulin

    Time frame: change from baseline to 6 months

    Serum hormone binding globulin measured as percent change from baseline

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 24, 2011
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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