Administration of reduced glutathione in FOLFOX4 adjuvant treatment for colorectal cancer: effect on oxaliplatin pharmacokinetics, Pt-DNA adduct formation, and neurotoxicity.

Milla P, Airoldi M, Weber G, Drescher A, Jaehde U, Cattel L

Anti-cancer drugs1 Jun 2009Cited by 48 (Europe PMC)

PMID19287306DOI10.1097/cad.0b013e32832a2dc1PepBankPUB-19287306

Publisher page PubMedAsk about this study

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In colorectal cancer treated with FOLFOX4, glutathione reduced neurotoxicity compared with placebo at the end of treatment cycles.
In plain wordsIn colorectal cancer treated with FOLFOX4, glutathione reduced nerve toxicity compared with placebo.
Peptide
Glutathione
Outcome
DecreaseNeurotoxicity
Study
n = 27
Comparator
Saline solution
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
1500 mg/m before oxaliplatin infusionAs given in this study (human).
Measurements
P value
0.0037
neurotoxicity
Source sentences
Summary
At the end of all cycles of therapy, the patients in the GSH arm showed a statistically significant reduction of neurotoxicity (P=0.0037) compared with the placebo arm.
3 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated the effect of reduced glutathione administration on neurotoxicity, oxaliplatin pharmacokinetics, and platinum-DNA (Pt-DNA) adduct formation in patients affected by colorectal cancer treated with FOLFOX4 adjuvant regimen.
Summary · context
Twenty-seven patients were randomized to receive GSH 1500 mg/m or saline solution before oxaliplatin infusion.
Summary · context
Evaluation of neurotoxicity, pharmacokinetics of plasmatic total and ultrafiltered Pt, and determination of Pt-DNA adduct formation on white blood cells was performed during the 5th, 9th, and 12th cycles.
Report a problemFND-1928730601
02HumanRandomized controlled trialPharmacokinetics
In colorectal cancer treated with FOLFOX4, main platinum pharmacokinetic parameters other than AUC and Vss did not differ with glutathione versus saline.
In plain wordsIn colorectal cancer, most main platinum pharmacokinetic parameters did not significantly differ with glutathione versus saline.
Peptide
Glutathione
Outcome
No significant changeOther main platinum pharmacokinetic parameters
Study
n = 27
Comparator
Saline solution
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1500 mg/m before oxaliplatin infusionAs given in this study (human).
Source sentences
Summary
There were no significant differences in the main pharmacokinetic parameters between the two arms except a lower area under the plasma concentration-time curve and a smaller apparent steady-state volume of distribution (Vss) when GSH was coadministered.
3 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated the effect of reduced glutathione administration on neurotoxicity, oxaliplatin pharmacokinetics, and platinum-DNA (Pt-DNA) adduct formation in patients affected by colorectal cancer treated with FOLFOX4 adjuvant regimen.
Summary · context
Twenty-seven patients were randomized to receive GSH 1500 mg/m or saline solution before oxaliplatin infusion.
Summary · context
Evaluation of neurotoxicity, pharmacokinetics of plasmatic total and ultrafiltered Pt, and determination of Pt-DNA adduct formation on white blood cells was performed during the 5th, 9th, and 12th cycles.
Report a problemFND-1928730602
03HumanRandomized controlled trialPharmacokinetics
In colorectal cancer treated with FOLFOX4, glutathione reduced platinum plasma concentration-time area under the curve compared with saline.
In plain wordsIn colorectal cancer treated with FOLFOX4, glutathione reduced platinum exposure in plasma compared with saline.
Peptide
Glutathione
Outcome
DecreasePlatinum plasma concentration-time AUC
Study
n = 27
Comparator
Saline solution
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1500 mg/m before oxaliplatin infusionAs given in this study (human).
Source sentences
Summary
There were no significant differences in the main pharmacokinetic parameters between the two arms except a lower area under the plasma concentration-time curve and a smaller apparent steady-state volume of distribution (Vss) when GSH was coadministered.
3 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated the effect of reduced glutathione administration on neurotoxicity, oxaliplatin pharmacokinetics, and platinum-DNA (Pt-DNA) adduct formation in patients affected by colorectal cancer treated with FOLFOX4 adjuvant regimen.
Summary · context
Twenty-seven patients were randomized to receive GSH 1500 mg/m or saline solution before oxaliplatin infusion.
Summary · context
Evaluation of neurotoxicity, pharmacokinetics of plasmatic total and ultrafiltered Pt, and determination of Pt-DNA adduct formation on white blood cells was performed during the 5th, 9th, and 12th cycles.
Report a problemFND-1928730603
04HumanRandomized controlled trialPharmacokinetics
In colorectal cancer treated with FOLFOX4, glutathione reduced platinum apparent steady-state volume of distribution compared with saline.
In plain wordsIn colorectal cancer treated with FOLFOX4, glutathione reduced platinum's apparent volume of distribution compared with saline.
Peptide
Glutathione
Outcome
DecreasePlatinum apparent steady-state volume of distribution
Study
n = 27
Comparator
Saline solution
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1500 mg/m before oxaliplatin infusionAs given in this study (human).
Source sentences
Summary
There were no significant differences in the main pharmacokinetic parameters between the two arms except a lower area under the plasma concentration-time curve and a smaller apparent steady-state volume of distribution (Vss) when GSH was coadministered.
3 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated the effect of reduced glutathione administration on neurotoxicity, oxaliplatin pharmacokinetics, and platinum-DNA (Pt-DNA) adduct formation in patients affected by colorectal cancer treated with FOLFOX4 adjuvant regimen.
Summary · context
Twenty-seven patients were randomized to receive GSH 1500 mg/m or saline solution before oxaliplatin infusion.
Summary · context
Evaluation of neurotoxicity, pharmacokinetics of plasmatic total and ultrafiltered Pt, and determination of Pt-DNA adduct formation on white blood cells was performed during the 5th, 9th, and 12th cycles.
Report a problemFND-1928730604
05HumanRandomized controlled trialMechanism
In colorectal cancer treated with FOLFOX4, Pt-DNA adduct formation did not significantly differ with glutathione versus saline.
In plain wordsIn colorectal cancer treated with FOLFOX4, platinum binding to DNA did not significantly differ with glutathione versus saline.
Peptide
Glutathione
Outcome
No significant changePt-DNA adduct formation
Study
n = 27
Comparator
Saline solution
Outcome group
Receptor activity and mechanism · Cancer
Studied dose
1500 mg/m before oxaliplatin infusionAs given in this study (human).
Source sentences
Summary
The determination of Pt-DNA adduct formation shows no statistically significant differences between the two arms.
3 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated the effect of reduced glutathione administration on neurotoxicity, oxaliplatin pharmacokinetics, and platinum-DNA (Pt-DNA) adduct formation in patients affected by colorectal cancer treated with FOLFOX4 adjuvant regimen.
Summary · context
Twenty-seven patients were randomized to receive GSH 1500 mg/m or saline solution before oxaliplatin infusion.
Summary · context
Evaluation of neurotoxicity, pharmacokinetics of plasmatic total and ultrafiltered Pt, and determination of Pt-DNA adduct formation on white blood cells was performed during the 5th, 9th, and 12th cycles.
Report a problemFND-1928730605

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

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

Subjects

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