Evaluation of therapeutic effect of melatonin to improve nerve injury due to oxaliplati

Phase 3

• Conditions: Oxaliplatin- induced neuropathy, Chemotherapy- induced neuropathy.; Malignant neoplasm of overlapping sites of colon; C18.8

• Registration Number: IRCT20150726023349N5
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

All colon cancer patients with indication of adjuvant chemotherapy

Exclusion Criteria

All patients with history of DM or any form of peripheral nerve injury

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The reduction rate in percentage of the incidence of neuropathy in the involved patients receiving melatonin. Timepoint: Symptoms of neuropathy asked from the patients in the form of some questionnaire before, in the first 48 hours of beginning of chemotherapy and 1week later, after every course of chemotherapy. Method of measurement: collection of the information in the form of questionnaires: NCI- CTCAE? OSNS, NPSI, EORTC QLQ- C??.

Secondary Outcome Measures

Name	Time	Method
Prophylaxis for neuropathy in patients with colon cancer under treatment with oxaliplatin an irreversible complication of this treatment. Timepoint: one and half a year. Method of measurement: By neuromuscular evaluation (EMG and NCV) and physical examination and questionere.