IRCT20150726023349N5 IRCT 2022-11-28 Tehran University of Medical Sciences Evaluation of therapeutic effect of melatonin to improve nerve injury due to oxaliplatin OIPN Evaluation of melatonin efficacy in prophylaxis of Oxaliplatin induced acute peripheral neuropathy in FOLFOX regimen in patients with colon cancer 2022-09-23 anticipated 70 Complete https://irct.ir/trial/63436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the Restricted Randomization (Block Randomization) method. Blocking is usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps the researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process. The size of all the blocks is equal and we will have 10 blocks in this two-group experiment (including 5 participants in the intervention group and 5 participants in the control group). The randomization tool is to use a table of random numbers with even and odd numbers for the intervention and control groups, respectively. For concealment, we use allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the allocated group is not known before the individual is allocated. By using opaque letter envelopes sealed with a random sequence in (Sequentially numbered, sealed, opaque envelopes), each of the random sequences created in this method is recorded on a card and the cards are placed inside the letter envelopes in order They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: This is a double blind randomised control trial in outpatient clinic and medical oncology ward of cancer institute Neither the therapist nor the patient knows whether they have been given a placebo or a drug. 3 Oxaliplatin- induced neuropathy, Chemotherapy- induced neuropathy. 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 company) every night before sleeping for three months along with 1st to 6th course of their chemotherapy. Intervention 2: Control group: 1. receiving FOLFOX chemotherapy containing oxaliplatin , receiving placebo ,One pill (manufactured by Jalinous pharmaceutical company) every night before sleeping for three months along with 1st to 6th course of their chemotherapy. Yes - There is a plan to make this available What will be shared: The personal information of patients is not available for individuals but if needed we search them in the medical file and finally we release them as some questionair and analyse them When: Informationd are available from January 8, 2022 until September 23,2023 To whom: Informations are available for the researchers of academic institutions Conditions: Informations are available for the reaserchers in academic institutions and all physicians and reaserchers in hospitals and medical clinics Where to obtain: 1. homa.razavi84@yahoo.com 2. sfandbod@sina.tums.ac.ir12345 How to obtain: With contacting to mentioned Email addresses, the informations are reachable in two weeks after receiving the Email Comments: