Efficacy of melatonin for the treatment of moderate to severe vincristine-induced neuropathy in pediatric malignancies
Phase 3
Recruiting
- Conditions
- chemotherapy induced neuropathy.Polyneuropathy in neoplastic diseaseG63.1*
- Registration Number
- IRCT20200710048068N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Age: 6-12 years old
Patients with ALL
Incidence of neuropathy following receiving vincristine
Exclusion Criteria
Hypersensitivity to melatonin
Patients over 12 years of age
CNS tumor (except meduloblastoma), focal neurological symptoms, CN metastasis
Other neuromuscular disorders (traumatic brain injury, cerebral palsy)
Recurrent diseases
Unstable hemodynamic status
Amputation of upper and lower limbs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method europathy. Timepoint: The second and fourth weeks after starting treatment. Method of measurement: ped-mTNS and PCIN questionnaires.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: The second and fourth weeks after starting treatment. Method of measurement: Peds QL Questionnaire.