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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Ruth E. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01302379
First received: February 23, 2011
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.


Condition Intervention
Breast Neoplasms
Drug: Metformin
Drug: Placebo
Behavioral: Lifestyle intervention
Behavioral: Standard printed dietary guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Biological markers associated with breast cancer survival [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin + lifestyle 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
Behavioral: Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Active Comparator: Placebo + lifestyle intervention Drug: 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
Other Name: Sugar pill
Behavioral: Lifestyle intervention
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Active Comparator: Metformin + standard dietary guidelines 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
Behavioral: Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)
Placebo Comparator: Placebo + standard dietary guidelines Drug: 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
Other Name: Sugar pill
Behavioral: Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302379

Contacts
Contact: Jesica Oratowski Coleman 8588223311 joratowski@ucsd.edu
Contact: Lisa Bertram, PhD 8588226799 lcadmus@ucsd.edu

Locations
United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Ruth E Patterson, PhD         
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Ruth E. Patterson, Professor, Department of Family & Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01302379     History of Changes
Other Study ID Numbers: U54 CA155435-01 Project 3
Study First Received: February 23, 2011
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Obesity
Survival
Weight loss
Metformin
Biological markers

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Body Weight
Breast Diseases
Neoplasms
Neoplasms by Site
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Skin Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014