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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539053
• Other study ID #: 65068
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• N Acetylcysteine A
paclitaxel + N-Acetylcysteine orally short course
• N Acetylcysteine B
paclitaxel +N Acetylcysteine orally long course

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects of NAC	Nausea, vomiting, diarrhea, abdominal discomfort, allergy	At the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)
Primary	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	Severity of paclitaxel-induce peripheral neuropathy	Assessment of severity of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ)	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	Quality of life associated paclitaxel-induce peripheral neuropathy	Assessment of quality of life using FACT/GOG-Ntx	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)