Clinical trial NCT05539053: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2022-09-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Paclitaxel-induce peripheral neuropathy
timeFrame: 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:
measure: Severity of paclitaxel-induce peripheral neuropathy
timeFrame: 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)
measure: Quality of life associated paclitaxel-induce peripheral neuropathy
timeFrame: 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:
measure: Side effects of NAC
timeFrame: At the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: