Chemotherapy-induced Peripheral Neuropathy
Conditions
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)
Interventions
DRUGN Acetylcysteine A
paclitaxel + N-Acetylcysteine orally short course
DRUGN Acetylcysteine B
paclitaxel +N Acetylcysteine orally long course
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed