North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled study.

Leal AD, Qin R, Atherton PJ, Haluska P, Behrens RJ, Tiber CH, Watanaboonyakhet P, Weiss M, Adams PT, Dockter TJ, Loprinzi CL

Cancer11 Mar 2014Cited by 64 (Europe PMC)

PMID24619793PMCIDPMC4047184DOI10.1002/cncr.28654PepBankPUB-24619793

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel and carboplatin, GSH did not significantly differ from placebo on CIPN20 sensory neurotoxicity.
In plain wordsIn patients receiving paclitaxel and carboplatin, sensory nerve toxicity did not differ significantly between GSH and placebo.
Peptide
Glutathione
Outcome
No significant changeCIPN20 sensory peripheral neurotoxicity
Study
n = 185
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value for CIPN20 sensory neurotoxicity
0.21 p value
Glutathione versus placebo, CIPN20 sensory neurotoxicity
Source sentences
Summary
There were no statistically significant differences between the 2 study arms with regard to: 1) peripheral neurotoxicity, as assessed using both the EORTC-QLQ-CIPN20 (P = .21)
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979301
02HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel and carboplatin, GSH did not significantly differ from placebo for grade ≥2 neurotoxicity.
In plain wordsIn patients receiving paclitaxel and carboplatin, clinically graded nerve toxicity did not differ significantly between GSH and placebo.
Peptide
Glutathione
Outcome
No significant changeCTCAE grade ≥2 neurotoxicity
Study
n = 185
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value for CTCAE grade ≥2 neurotoxicity
0.449 p value
Glutathione versus placebo, CTCAE grade ≥2 neurotoxicity
Source sentences
Summary
There were no statistically significant differences between the 2 study arms with regard to: 1) peripheral neurotoxicity, as assessed using both the EORTC-QLQ-CIPN20 (P = .21) and the CTCAE scales (P = .449 for grade ≥2 neurotoxicity;
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979302
03HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel and carboplatin, time to grade ≥2 neuropathy favored placebo over GSH.
In plain wordsIn chemotherapy patients, the time until nerve damage favored placebo over GSH.
Peptide
Glutathione
Outcome
DecreaseTime to grade ≥2 neuropathy
Study
n = 185
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value for time to development of grade ≥2 neuropathy
0.039 p value
Glutathione versus placebo, time to development of grade ≥2 neuropathy
Source sentences
Summary
P = .039 for time to development of grade ≥2 neuropathy, in favor of the placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979303
04HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel and carboplatin, GSH did not significantly differ from placebo for time to disease progression.
In plain wordsIn patients receiving paclitaxel and carboplatin, time to disease progression did not differ significantly between GSH and placebo.
Peptide
Glutathione
Outcome
No significant changeTime to disease progression
Study
n = 185
Comparator
Placebo
Outcome group
Tumor growth · Cancer
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value
0.63
Time to disease progression, glutathione versus placebo
Source sentences
Summary
3) the time to disease progression (P = .63)
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979306
05HumanRandomized controlled trialSafety outcome
In patients receiving paclitaxel and carboplatin, apparent toxicities did not significantly differ between GSH and placebo.
In plain wordsIn chemotherapy patients, apparent toxicities did not differ significantly between GSH and placebo.
Peptide
Glutathione
Outcome
No significant changeApparent toxicities
Study
n = 185
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1.5 g/m(2)As given in this study (human).
Source sentences
Summary
There were no statistically significant differences between the 2 study arms with regard to:
Summary
4) apparent toxicities.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979307
06HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel every 3-4 weeks, GSH did not significantly differ from placebo for acute pain syndrome.
In plain wordsIn patients receiving paclitaxel every 3-4 weeks, acute pain did not differ significantly between GSH and placebo.
Peptide
Glutathione
Outcome
No significant changeAcute pain with paclitaxel every 3-4 weeks
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value for acute pain syndrome with paclitaxel every 3-4 weeks
0.3 p value
Glutathione versus placebo, acute pain syndrome with paclitaxel every 3-4 weeks
Source sentences
Summary
2) the degree of paclitaxel acute pain syndrome (P = .30 for patients who received paclitaxel every 3-4 weeks
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979304
07HumanRandomized controlled trialEfficacy outcome
In patients receiving weekly paclitaxel, acute pain syndrome favored placebo over GSH.
In plain wordsIn patients receiving weekly paclitaxel, acute pain outcomes favored placebo over GSH.
Peptide
Glutathione
Outcome
IncreaseAcute pain with weekly paclitaxel
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Measurements
P value for acute pain syndrome with weekly paclitaxel
0.002 p value
Glutathione versus placebo, acute pain syndrome with weekly paclitaxel
Source sentences
Summary
2) the degree of paclitaxel acute pain syndrome (P = .30 for patients who received paclitaxel every 3-4 weeks and P = .002, in favor of the placebo, for patients who received weekly paclitaxel)
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979305
08HumanRandomized controlled trialEfficacy outcome
In patients receiving paclitaxel and carboplatin, subgroup analyses found no evidence of GSH benefit in any subgroup.
In plain wordsIn chemotherapy patients, subgroup analyses found no benefit from GSH compared with placebo.
Peptide
Glutathione
Outcome
No significant changeSubgroup benefit
Study
n: not reported in source
Comparator
Placebo
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1.5 g/m(2)As given in this study (human).
Source sentences
Summary
Subgroup analyses did not reveal any evidence of benefit in any particular subgroup.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011.
Summary · context
Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy.
Report a problemFND-2461979308

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PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled study.

Summary

Results from this study8

Version history

Subjects

Publication types

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Keywords