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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05539053
Collaborator
(none)
60
Enrollment
3
Arms
13.9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: N Acetylcysteine A
  • Drug: N Acetylcysteine B
 N/A

Detailed Description

This study was designed to evaluate the effect of NAC on the incidence and severity of PIPN in woman with ovarian, tubal, and peritoneal cancer who treated with paclitaxel for 3 cycles. (PIPPN is developed after cumulative doses 250 mg/m2 or more) Patient in controlled group, received Paclitaxel only. Patient in intervention group divided to two groups. First group received NAC 2400 mg/day for one week after received Paclitaxel each cycle for 3 cycles. Second group received NAC 2400 mg/day for 9 weeks Evaluate incidence and severity of PIPN before start CMT, and every visit after received CMT each cycle using Common Terminology Criteria for Adverse Event (CTCAE) ver.5, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and Patient Neurotoxicity Questionnaire (PNQ)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of N-acetylcysteine for the Prevention and Relief of Paclitaxel-induced Peripheral Neuropathy in Women With Ovarian, Tubal, and Peritoneal Cancer: an Open-label, Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NAC short course

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

Drug: N Acetylcysteine A
paclitaxel + N-Acetylcysteine orally short course
Experimental: NAC long course

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

Drug: N Acetylcysteine B
paclitaxel +N Acetylcysteine orally long course
No Intervention: control

patient received CMT(Paclitaxel) only

Outcome Measures

Primary Outcome Measures

  1. 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)]

    Assessment of grade of peripheral neuropathy by CTCAE v.5.0

Secondary Outcome Measures

  1. 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)]

    Assessment of severity of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ)

  2. 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)]

    Assessment of quality of life using FACT/GOG-Ntx

Other Outcome Measures

  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)]

    Nausea, vomiting, diarrhea, abdominal discomfort, allergy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT05539053
Other Study ID Numbers:
  • 65068
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Acetylcysteine
N-monoacetylcystine

Study Results

No Results Posted as of Sep 14, 2022