NCT05539053Completed
Efficacy of NAC for the Prevention and Relief of PIPN in Women With Ovarian, Tubal, and Peritoneal Cancer
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
Source: ClinicalTrials.gov · Last updated 25 Jan 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 27 Jul 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Diseases
- Ovarian cancer
- NCT number
- NCT05539053
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Nov 2022 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of treated with other chemotherapy or radiotherapy before study
Other illness
- Allergy to N-acetylcysteine
- Psychiatric disorders
Other
- Patient with symptoms of peripheral neuropathy before study
- Pregnant woman
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.