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

NCT05539053 | Completed DMC

• 1 other identifier: 65068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Paclitaxel-induce peripheral neuropathy

  Assessment of grade of peripheral neuropathy by CTCAE v.5.0

  Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)

Secondary Outcomes (2)

• Severity of paclitaxel-induce peripheral neuropathy

  Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)

• Quality of life associated paclitaxel-induce peripheral neuropathy

  Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)

Other Outcomes (1)

• Side effects of NAC

  At the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)

Study Arms (3)

NAC short course

EXPERIMENTAL

patient received CMT(Paclitaxel) and NAC 2400 mg/day one week per each cycle of CMT

Drug: N Acetylcysteine A

NAC long course

EXPERIMENTAL

patient received CMT(Paclitaxel) and NAC 2400 mg/day every day for 9 weeks

Drug: N Acetylcysteine B

control

NO INTERVENTION

patient received CMT(Paclitaxel) only

Interventions

N Acetylcysteine A DRUG

paclitaxel + N-Acetylcysteine orally short course

NAC short course

N Acetylcysteine B DRUG

paclitaxel +N Acetylcysteine orally long course

NAC long course

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient aged 18 years old or more with ovarian, tubal, and peritoneal cancer who received Paclitaxel first course after surgery
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Normal laboratory testing
• hemoglobin ≥10 g/dL, leukocyte count ≥ 3,000/mL, absolute neutrophil count ≥1,500/mL, platelet count ≥100,000/mL
• Serum creatinine ≤1.5 mg/dL
• Bilirubin ≤1.5 upper limit of normal
• Alkaline phosphatase and serum glutamic oxaloacetate transaminase ≤3 upper limit of normal

You may not qualify if:

• Patient with symptoms of peripheral neuropathy before study
• Allergy to N-acetylcysteine
• Psychiatric disorders
• Pregnant woman
• History of treated with other chemotherapy or radiotherapy before study

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

poly(methyl methacrylate)-b-polycaprolactone-N-acetylcysteine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: September 14, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2023-02

Locations

TH (1)