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Efficacy of melatonin for the treatment of moderate to severe vincristine-induced neuropathy in pediatric malignancies

Efficacy of melatonin for the treatment of moderate to severe vincristine-induced neuropathy in pediatric malignancies

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200710048068N1
Enrollment
20
Registered
2022-06-21
Start date
2022-04-09
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemotherapy induced neuropathy. Polyneuropathy in neoplastic disease

Interventions

Intervention 1: Intervention group: Patients receive melatonin (weight less than 40 kg: 3 mg, weight more than 40 kg: 5 mg) for 30 days 4 hours before bedtime and after dinner. Intervention 2: Control

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Age: 6-12 years old Patients with ALL Incidence of neuropathy following receiving vincristine

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Neuropathy. Timepoint: The second and fourth weeks after starting treatment. Method of measurement: ped-mTNS and PCIN questionnaires.

Secondary

MeasureTime frame
Quality of life. Timepoint: The second and fourth weeks after starting treatment. Method of measurement: Peds QL Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactToktam Faghihi

Tehran University of Medical Sciences

tfaghihi@razi.tums.ac.ir+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026