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NCT00775645 · ClinicalTrials.gov registry record · Phase 3
S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 437
- Enrollment target
NCT00775645: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00775645 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 437 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00775645, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 437 participants
- Enrollment target
Study Summary
RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
Primary Outcome
Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT acetyl-L-carnitine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00775645 record still lists
NCT00775645 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00775645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00775645 about?
NCT00775645 is a clinical study titled "S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo". RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how ...
What is the current status of trial NCT00775645?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 437 participants. The study started on 2009-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00775645?
The interventions under investigation include: placebo (OTHER), acetyl-L-carnitine hydrochloride (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00775645?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00775645's enrollment target sits among peer trials
437 874th of 2000 higher than 1,127 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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