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

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
N Acetylcysteine A
N Acetylcysteine B
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

NAC short course

NAC long course

control

Arm Description

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

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

patient received CMT(Paclitaxel) only

Outcomes

Primary Outcome Measures

Paclitaxel-induce peripheral neuropathy
Assessment of grade of peripheral neuropathy by CTCAE v.5.0

Secondary Outcome Measures

Severity of paclitaxel-induce peripheral neuropathy
Assessment of severity of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ)
Quality of life associated paclitaxel-induce peripheral neuropathy
Assessment of quality of life using FACT/GOG-Ntx

Full Information

First Posted
July 27, 2022
Last Updated
February 16, 2023
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05539053
Brief Title
Efficacy of NAC for the Prevention and Relief of PIPN in Women With Ovarian, Tubal, and Peritoneal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAC short course
Arm Type
Experimental
Arm Description
patient received CMT(Paclitaxel) and NAC 2400 mg/day one week per each cycle of CMT
Arm Title
NAC long course
Arm Type
Experimental
Arm Description
patient received CMT(Paclitaxel) and NAC 2400 mg/day every day for 9 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
patient received CMT(Paclitaxel) only
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine A
Intervention Description
paclitaxel + N-Acetylcysteine orally short course
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine B
Intervention Description
paclitaxel +N Acetylcysteine orally long course
Primary Outcome Measure Information:
Title
Paclitaxel-induce peripheral neuropathy
Description
Assessment of grade of peripheral neuropathy by CTCAE v.5.0
Time Frame
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 Outcome Measure Information:
Title
Severity of paclitaxel-induce peripheral neuropathy
Description
Assessment of severity of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ)
Time Frame
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)
Title
Quality of life associated paclitaxel-induce peripheral neuropathy
Description
Assessment of quality of life using FACT/GOG-Ntx
Time Frame
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 Pre-specified Outcome Measures:
Title
Side effects of NAC
Description
Nausea, vomiting, diarrhea, abdominal discomfort, allergy
Time Frame
At the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wichuda deechanda
Phone
093-1951818
Email
ammwd.wichuda@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marut Yanaranop
Phone
081-3450015
Email
Marut.y@rsu.ac.th
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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