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

NCT01302379 | Completed Results DMC

• 2 other identifiers: U54 CA155435-01 Project 3U54CA155435-01
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

Obesity; Survival; Weight loss; Metformin; Biological markers

Outcome Measures

Primary Outcomes (5)

• Insulin

  Insulin measured as percent change from baseline

  change from baseline to 6 months

• Glucose

  Glucose measured as percent change from baseline

  change from baseline to 6 months

• C-reactive Protein

  C-reactive protein measured as percent change from baseline

  change from baseline to 6 months

• Bioavailable Testosterone

  Bioavailable testosterone measured as percent change from baseline

  change from baseline to 6 months

• Serum Hormone Binding Globulin

  Serum hormone binding globulin measured as percent change from baseline

  change from baseline to 6 months

Study Arms (4)

Metformin + lifestyle intervention

ACTIVE COMPARATOR

Drug: Metformin; Behavioral: Lifestyle intervention

Placebo + lifestyle intervention

ACTIVE COMPARATOR

Drug: Placebo; Behavioral: Lifestyle intervention

Metformin + standard dietary guidelines

ACTIVE COMPARATOR

Drug: Metformin; Behavioral: Standard printed dietary guidelines

Placebo + standard dietary guidelines

PLACEBO COMPARATOR

Drug: Placebo; Behavioral: Standard printed dietary guidelines

Interventions

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

Metformin + lifestyle intervention; Metformin + standard dietary guidelines

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

Also known as: Sugar pill

Placebo + lifestyle intervention; Placebo + standard dietary guidelines

Lifestyle intervention BEHAVIORAL

Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.

Metformin + lifestyle intervention; Placebo + lifestyle intervention

Standard printed dietary guidelines BEHAVIORAL

Set of standard health education materials provided to participants at single time point (immediately after randomization)

Metformin + standard dietary guidelines; Placebo + standard dietary guidelines

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (2)

• Bellerba F, Chatziioannou AC, Jasbi P, Robinot N, Keski-Rahkonen P, Trolat A, Vozar B, Hartman SJ, Scalbert A, Bonanni B, Johansson H, Sears DD, Gandini S. Metabolomic profiles of metformin in breast cancer survivors: a pooled analysis of plasmas from two randomized placebo-controlled trials. J Transl Med. 2022 Dec 29;20(1):629. doi: 10.1186/s12967-022-03809-6.

  PMID: 36581893 DERIVED

• Nwanaji-Enwerem JC, Chung FF, Van der Laan L, Novoloaca A, Cuenin C, Johansson H, Bonanni B, Hubbard AE, Smith MT, Hartman SJ, Cardenas A, Sears DD, Herceg Z. An epigenetic aging analysis of randomized metformin and weight loss interventions in overweight postmenopausal breast cancer survivors. Clin Epigenetics. 2021 Dec 17;13(1):224. doi: 10.1186/s13148-021-01218-y.

  PMID: 34920739 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Weight Loss

Interventions

Metformin; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Ruth Patterson
• Organization: University of San Diego, California

repatterson@ucsd.edu

8585349235

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Family & Preventive Medicine

Model Details: Main effects of the factorial design were the planned primary analysis and what the study was powered on.

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 5, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-05

Locations

US (1)