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

Rajavithi Hospital

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Drug: N Acetylcysteine A; Drug: N Acetylcysteine B

Study type: Interventional

Funder types: Other

Identifiers

NCT05539053

65068

Details and patient eligibility

About

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

Full 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)

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

NAC short course

Experimental group

Description:

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

Treatment:

Drug: N Acetylcysteine A

NAC long course

Experimental group

Description:

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

Treatment:

Drug: N Acetylcysteine B

control

No Intervention group

Description:

patient received CMT(Paclitaxel) only