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NCT02360059 · ClinicalTrials.gov registry record · Phase 2
Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02360059: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02360059 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02360059, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if metformin can help to control nerve damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in patients with breast cancer. In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Primary Outcome
Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas \[AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights corr
Interventions
- OTHER Placebo
- DRUG Metformin
- BEHAVIORAL Questionnaires
- OTHER Sensory and Fine-Motor Tests
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Why NCT02360059 stopped before completion
NCT02360059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02360059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02360059 about?
NCT02360059 is a clinical study titled "Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer". The goal of this clinical research study is to learn if metformin can help to control nerve damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in patients with breast cancer. In this study, metformin will be compared to a placebo. A placebo is not a drug. It ...
What is the current status of trial NCT02360059?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2015-10. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02360059?
The interventions under investigation include: Placebo (OTHER), Metformin (DRUG), Questionnaires (BEHAVIORAL), Sensory and Fine-Motor Tests (OTHER).
Who is sponsoring clinical trial NCT02360059?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02360059's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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