CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 437 enrolled
Drug / intervention
acetyl-L-carnitine hydrochloride +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00775645
NCT00775645Phase 3Completed
CompareCT.gov

S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III

SWOG Cancer Research Network·interventional·Posted Oct 20, 2008·Updated Aug 14, 2017

In Brief

A Phase 3 clinical trial evaluating acetyl-L-carnitine hydrochloride and placebo for Breast Cancer and 4 related conditions. Completed, enrolled 437 participants across 295 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Chemotherapeutic Agent Toxicity, Fatigue, Neuropathy, Neurotoxicity
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2008
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.7 years ago

Interventions

acetyl-L-carnitine hydrochloridedietary

Given orally

placeboother

Given orally