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NCT01340300 · ClinicalTrials.gov registry record · Phase 2
Exercise and Metformin in Colorectal and Breast Cancer Survivors
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
NCT01340300: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01340300 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 139 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340300, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
Study Summary
Metformin is a medication that is commonly used in the treatment of diabetes. Recently small studies in cancer patients without diabetes suggest that metformin may benefit in lowering insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar) levels in the blood are generally no lowered. Insulin and insulin-like growth factors affect the growth of cancer cells. This randomized study will compare different interventions; exercise, exercise and metformin, metformin alone, or a control arm. The investigators are not directly testing how either exercise or metformin affects your disease. The investigators are testing how they affect insulin levels in your body as well as other blood markers. The investigators believe that these blood tests may either be related to cancer recurrences or be an early sign of cancer recurrences and they are testing how both exercise and metformin may change those markers.
Primary Outcome
Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.
Interventions
- DRUG Metformin
- BEHAVIORAL Exercise training
- OTHER Educational information
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2011-05 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
What the finished NCT01340300 record still lists
NCT01340300 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01340300 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01340300 about?
NCT01340300 is a clinical study titled "Exercise and Metformin in Colorectal and Breast Cancer Survivors". Metformin is a medication that is commonly used in the treatment of diabetes. Recently small studies in cancer patients without diabetes suggest that metformin may benefit in lowering insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar) levels in the blood ar...
What is the current status of trial NCT01340300?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2011-05. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01340300?
The interventions under investigation include: Metformin (DRUG), Exercise training (BEHAVIORAL), Educational information (OTHER).
Who is sponsoring clinical trial NCT01340300?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01340300's enrollment target sits among peer trials
139 525th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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