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NCT00195013 · ClinicalTrials.gov registry record · Phase 3
Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00195013: Completed Phase 3 study, sponsored by Weill Medical College of Cornell University.
NCT00195013 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195013, a Phase 3 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.
Primary Outcome
Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result). Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity.
Interventions
- DRUG Placebo
- DRUG glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2003-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT00195013 record still lists
NCT00195013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00195013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00195013 about?
NCT00195013 is a clinical study titled "Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy". Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.
What is the current status of trial NCT00195013?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2003-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00195013?
The interventions under investigation include: Placebo (DRUG), glutamine (DRUG).
Who is sponsoring clinical trial NCT00195013?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00195013's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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