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

Breast Neoplasms Clinical Trial

Official title:

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302379
• Other study ID #: U54 CA155435-01 Project 3
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 ß-blockers

• Taking insulin or other antidiabetic drug

• Other primary or recurrent invasive cancer in past 10 years

• Unable to commit to study requirements

Related Conditions & MeSH terms

• Breast Neoplasms
• Obesity

Intervention

Drug:
• 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
• 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

Behavioral:
• Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
• Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin	Insulin measured as percent change from baseline	change from baseline to 6 months
Primary	Glucose	Glucose measured as percent change from baseline	change from baseline to 6 months
Primary	C-reactive Protein	C-reactive protein measured as percent change from baseline	change from baseline to 6 months
Primary	Bioavailable Testosterone	Bioavailable testosterone measured as 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	change from baseline to 6 months