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

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2011

Last Updated Date

August 27, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01302379 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

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
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.
Behavioral: Standard printed dietary guidelines
Set of standard health education materials provided to participants at single time point (immediately after randomization)

Study Arm (s)

Active Comparator: Metformin + lifestyle intervention
Interventions:
- Drug: Metformin
- Behavioral: Lifestyle intervention
Active Comparator: Placebo + lifestyle intervention
Interventions:
- Drug: Placebo
- Behavioral: Lifestyle intervention
Active Comparator: Metformin + standard dietary guidelines
Interventions:
- Drug: Metformin
- Behavioral: Standard printed dietary guidelines
Placebo Comparator: Placebo + standard dietary guidelines
Interventions:
- Drug: Placebo
- Behavioral: Standard printed dietary guidelines

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

340

Estimated Completion Date

July 2016

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01302379

Other Study ID Numbers ^ICMJE

U54 CA155435-01 Project 3

Has Data Monitoring Committee

Yes

Responsible Party

Ruth E. Patterson, University of California, San Diego

Study Sponsor ^ICMJE

University of California, San Diego

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of California, San Diego

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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