Evidence map›Paper›PMID 23733756›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy.

Dawn L Hershman, Joseph M Unger, Katherine D Crew, Lori M Minasian, Danielle Awad, Carol M Moinpour, Lisa Hansen, Danika L Lew, Heather Greenlee, Louis Fehrenbacher and 5 more

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 100 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 7 pooled it
9.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00775645 phase3completednot on this map

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

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2009 to 2013Enrolled437ConditionsBreast Cancer, Chemotherapeutic Agent Toxicity, Fatigue, NeuropathyArmsacetyl-L-carnitine hydrochloride, placebo
NCT05601479 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Preventive Effect of Acetyl-L-carnitine on Oxaliplatin-induced Peripheral Neuropathy: A Randomized, Controlled, Open-label, Phase 2 Trail

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2022 to 2024Enrolled100ConditionsAcetylcarnitine, Chemotherapy-induced Peripheral NeuropathyArmsAcetyl-L-carnitine
NCT07109817 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)

TypeinterventionalSponsorMontefiore Medical CenterRan2026 to 2030Enrolled116ConditionsBreast Cancer, Peripheral NeuropathyArmsDesloratodine, Placebo
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 7 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
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  9. Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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  13. Neu-horizons: neuroprotection and therapeutic use of riluzole for the prevention of oxaliplatin-induced neuropathy-a randomised controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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  16. Cold therapy to prevent paclitaxel-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Dawn L HershmanColumbia University, 161 Fort Washington Ave, 10-1068, New York, NY 10032, USA. dlh23@columbia.edu
Joseph M Unger
Katherine D Crew
Lori M Minasian
Danielle Awad
Carol M Moinpour
Lisa Hansen
Danika L Lew
Heather Greenlee
Louis Fehrenbacher
James L Wade
Siu-Fun Wong
Gabriel N Hortobagyi
Frank L Meyskens
Kathy S Albain
SWOG Cancer Research Network · US

Funding

SWOG Foreign AccrualsU10CA037429 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI BLANKE, CHARLES D., MEYSKENS, FRANK L. · 1985 to 2014
$205.2M
Medical Research Council G0701870NCI NIH HHS CA037429NCI NIH HHS U10 CA037429PHS HHS ULR000040
6 · The paper itself

Abstract

purposeChemotherapy-induced peripheral neuropathy (CIPN) is common and leads to suboptimal treatment. Acetyl-L-carnitine (ALC) is a natural compound involved in neuronal protection. Studies have suggested ALC may be effective for the prevention and treatment of CIPN. PATIENTS AND

methodsA 24-week randomized double-blind trial comparing ALC (3,000 mg per day) with placebo in women undergoing adjuvant taxane-based chemotherapy was conducted. The primary objective was to determine if ALC prevents CIPN as measured by the 11-item neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) -Taxane scale at 12 weeks. Secondary objectives included changes in 24-week end points, functional status (FACT-Trial Outcome Index [TOI]), fatigue (Functional Assessment of Chronic Illness Therapy [FACIT] -Fatigue), and NTX grade.

resultsA total of 409 patients were evaluable (208 received ALC; 201, placebo). In a multivariate linear regression, week-12 scores were 0.9 points lower (more CIPN) with ALC than placebo (95% CI, -2.2 to 0.4; P = .17), whereas week-24 scores were 1.8 points lower with ALC (95% CI, -3.2 to -0.4; P = .01). Patients receiving ALC were more likely to have a > 5-point decrease in FACT-NTX scores (38% v 28%; P = .05), and FACT-TOI scores were 3.5 points lower with ALC (P = .03). Grade 3 to 4 neurotoxicity was more frequent in the ALC arm (eight v one). No differences between arms were observed for FACIT-Fatigue or other toxicities. Serum carnitine level increased with ALC but remained stable with placebo.

conclusionThere was no evidence that ALC affected CIPN at 12 weeks; however, ALC significantly increased CIPN by 24 weeks. This is the first study to our knowledge showing that a nutritional supplement increased CIPN. Patients should be discouraged from using supplements without proven efficacy.

Indexed as

AcetylcarnitineAdultAgedBreast NeoplasmsChemotherapy, AdjuvantDietary SupplementsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansLinear ModelsMastectomyMiddle AgedMultivariate AnalysisAcetylcarnitineTaxoids

Identifiers

PMID23733756
PMCPMC3699727
OpenAlexW2150112288

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.