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

In this study, the effectiveness of melatonin in the treatment of moderate to severe neuropathies induced by vincristine in pediatric malignancies was investigated.

Randomized, two-blinded, parallel, placebo-controlled clinical trial with 10 patients in each group.

This two blind study will be done in Tehran Pediatric Medical Center. Health care providers and patients are blind. Patients with vincristine-induced neuropathy fall into two groups using block randomization. One group received placebo and other received melatonin. In the treatment group, patients receive melatonin (weight less than 40 kg: 3 mg, weight more than 40 kg: 5 mg) daily for 30 days 4 hours before bedtime and after dinner. In the placebo group, the placebo tablet will be received for 30 days too. Patients will be evaluated every two weeks, ie the second and fourth weeks. In each assessment, children are evaluated for the extent of neuropathy, timing of complete recovery and quality of life.

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, CNS metastasis, Other neuromuscular disorders (traumatic brain injury, cerebral palsy), Recurrent diseases , Unstable hemodynamic status, Amputation of upper and lower limbs

Intervention group: Melatonin tablet will be taken. Control group: Placebo tablet will be taken.

Neuropathy

Randomization method of this study is permuted block randomization individually. The randomized list of numbers 1 to 20 is randomly divided into two groups A or B, and the admitted patients are listed in group A or B, respectively.

This study is a two blind clinical trial conducted at children's medical center. The producing company were asked to produce the melatonin pills and placebo pills with the same app so that they are indistinguishable from each other. The drugs were delivered to the researcher in 2 separate packages (packet number 1 and packet number 2), One packet was a placebo pill and the other was a melatonin pill. In a sealed letter the content of each group were revealed. Patients, researcher and statistic expert were blinded.

The data like check list and demographic data will be published in form of article.

At the end of study and after publication

Scientific researchers

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Toktam Faghihi

After acceptance by Toktam Faghihi