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Efficacy of NAC for the Prevention and Relief of PIPN in Women With Ovarian, Tubal, and Peritoneal Cancer

NCT05539053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-25

No results posted yet for this study

Summary

Ovarian cancer is third most common gynecologic cancer in Thai woman, treatment including surgery followed by chemotherapy.

Patient usually received paclitaxel every 3 week for 6 cycles, paclitaxel induce peripheral neuropathy is common dose dependent side effect which can disturb quality of life, result in chemotherapy dose reduction or discontinuation leading to poor prognosis and decreased survival Mechanism of PIPN including inflammation, promotion of microtubule polymerization and inhibition of depolymerization, and oxidative stress N-acetylcysteine is acetylated form of l-cysteine, might reduce oxidative stress. NAC can restore glutathione level, which is potent natural antioxidant. NAC might reduce PIPN

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

N Acetylcysteine A

paclitaxel + N-Acetylcysteine orally short course

DRUG

N Acetylcysteine B

paclitaxel +N Acetylcysteine orally long course

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-11-30
Completion
2023-12-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539053 on ClinicalTrials.gov