Neuroprotective effect of reduced glutathione on oxaliplatin-based chemotherapy in advanced colorectal cancer: a randomized, double-blind, placebo-controlled trial.

Cascinu S, Catalano V, Cordella L, Labianca R, Giordani P, Baldelli AM, Beretta GD, Ubiali E, Catalano G

Journal of clinical oncology : official journal of the American Society of Clinical Oncology1 Aug 2002Cited by 223 (Europe PMC)

PMID12177109DOI10.1200/jco.2002.07.061PepBankPUB-12177109

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

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

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, response rates were 26.9% with glutathione and 23.1% with placebo, with no reduction in oxaliplatin activity.
In plain wordsIn advanced colorectal cancer receiving oxaliplatin, response rates were 26.9% with glutathione and 23.1% with placebo, without reduced oxaliplatin activity.
Peptide
Glutathione
Outcome
No significant changeTumor response rate
Study
n = 52
Comparator
Normal saline solution
Outcome group
Tumor growth · Cancer
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Measurements
Response rate
26.9%
glutathione
Response rate
23.1%
placebo
Source sentences
Summary
The response rate was 26.9% in the GSH arm and 23.1% in the placebo arm, showing no reduction in activity of oxaliplatin.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710906
02HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, neurotoxicity affected nine of 21 glutathione recipients versus 15 of 19 placebo recipients after the eighth cycle.
In plain wordsIn colorectal cancer receiving oxaliplatin, neurotoxicity affected nine of 21 glutathione recipients versus 15 of 19 placebo recipients after the eighth cycle.
Peptide
Glutathione
Outcome
DecreaseNeurotoxicity after eighth cycle
Study
n = 40
Comparator
Normal saline solution
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Measurements
Neurotoxicity cases
9 patients
GSH arm, of 21 assessable patients
Neurotoxicity cases
15 patients
placebo arm, of 19 assessable patients
Assessable patients for neurotoxicity
21 patients
GSH arm, after eighth cycle
Assessable patients for neurotoxicity
19 patients
placebo arm, after eighth cycle
Source sentences
Summary
After the eighth cycle, nine of 21 assessable patients in the GSH arm suffered from neurotoxicity compared with 15 of 19 in the placebo arm.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710902
03HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, clinically evident neuropathy affected seven glutathione recipients versus 11 placebo recipients at the fourth cycle.
In plain wordsIn advanced colorectal cancer receiving oxaliplatin, neuropathy affected seven glutathione recipients versus 11 placebo recipients at the fourth cycle.
Peptide
Glutathione
Outcome
DecreaseClinically evident neuropathy at fourth cycle
Study
n: not reported in source
Comparator
Normal saline solution
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Measurements
Clinically evident neuropathy cases
7 patients
GSH arm, fourth cycle
Clinically evident neuropathy cases
11 patients
placebo arm, fourth cycle
Source sentences
Summary
At the fourth cycle, seven patients showed clinically evident neuropathy in the GSH arm, whereas 11 patients in the placebo arm did.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710901
04HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, grade 2 to 4 neuropathy affected two glutathione recipients versus 11 placebo recipients.
In plain wordsIn advanced colorectal cancer receiving oxaliplatin, grade 2 to 4 neuropathy affected two glutathione recipients versus 11 placebo recipients.
Peptide
Glutathione
Outcome
DecreaseGrade 2 to 4 neuropathy
Study
n: not reported in source
Comparator
Normal saline solution
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Measurements
Grade 2 to 4 neuropathy cases
2 patients
GSH arm
Grade 2 to 4 neuropathy cases
11 patients
placebo arm
P value
0.003
Grade 2 to 4 neuropathy: GSH arm versus placebo arm
Source sentences
Summary
With regard to grade 2 to 4 National Cancer Institute common toxicity criteria, 11 patients experienced neuropathy in the placebo arm compared with only two patients in the GSH arm (P =.003).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710903
05HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, grade 2 to 4 neurotoxicity affected three glutathione recipients versus eight placebo recipients after 12 cycles.
In plain wordsIn colorectal cancer receiving oxaliplatin, grade 2 to 4 neurotoxicity affected three glutathione recipients versus eight placebo recipients after 12 cycles.
Peptide
Glutathione
Outcome
DecreaseGrade 2 to 4 neurotoxicity after twelve cycles
Study
n: not reported in source
Comparator
Normal saline solution
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Measurements
Grade 2 to 4 neurotoxicity cases
3 patients
GSH arm, after 12 cycles
Grade 2 to 4 neurotoxicity cases
8 patients
placebo arm, after 12 cycles
P value
0.004
Grade 2 to 4 neurotoxicity after 12 cycles: GSH arm versus placebo arm
Source sentences
Summary
After 12 cycles, grade 2 to 4 neurotoxicity was observed in three patients in the GSH arm and in eight patients in the placebo arm (P =.004).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710904
06HumanRandomized controlled trialEfficacy outcome
In advanced colorectal cancer receiving oxaliplatin, sural sensory nerve conduction values did not significantly decline in the glutathione arm.
In plain wordsIn advanced colorectal cancer receiving oxaliplatin, sensory nerve conduction values did not significantly decline in the glutathione arm.
Peptide
Glutathione
Outcome
No significant changeSural sensory nerve conduction
Study
n: not reported in source
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1,500 mg/m(2) before oxaliplatin · infusion over 15 minutesAs given in this study (human).
Source sentences
Summary
The neurophysiologic investigations (sural sensory nerve conduction) showed a statistically significant reduction of the values in the placebo arm but not in the GSH arm.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity.
Summary · context
Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m(2) over a 15-minute infusion period before oxaliplatin) or normal saline solution.
Report a problemFND-1217710905

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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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