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NCT01302379 · ClinicalTrials.gov registry record · NA
Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 333
- Enrollment target
NCT01302379 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 333 participants.
The verdict
NCT01302379, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Metformin
- BEHAVIORAL Lifestyle intervention
- BEHAVIORAL Standard printed dietary guidelines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01302379
The ClinicalTrials.gov registry entry for NCT01302379 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01302379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01302379 about?
NCT01302379 is a clinical study titled "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 wil...
What is the current status of trial NCT01302379?
This trial is currently completed. It is a NA study. The enrollment target is 333 participants. The study started on 2011-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01302379?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lifestyle intervention (BEHAVIORAL), Standard printed dietary guidelines (BEHAVIORAL).
Who is sponsoring clinical trial NCT01302379?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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