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

Evaluation of melatonin efficacy in prophylaxis of Oxaliplatin induced acute peripheral neuropathy in FOLFOX regimen in patients with colon cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150726023349N5
Enrollment
70
Registered
2022-11-28
Start date
2022-09-23
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Oxaliplatin- induced neuropathy, Chemotherapy- induced neuropathy. Malignant neoplasm of overlapping sites of colon

Interventions

Intervention 1: Intervention group: 1. receiving FOLFOX chemotherapy containing oxaliplatin receiving melatonin tablets ,One pill with a dose of 10 mg (manufactured by Jalinous pharmaceutical compa

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All colon cancer patients with indication of adjuvant chemotherapy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoma Razavidehkordi

Tehran University of Medical Sciences

homa.razavi84@yahoo.com+98 21 6693 8083

Outcome results

None listed

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