1- Investigating the effect of melatonin in reducing the incidence of oxaliplatin acute neuropathy in colon cancer patients receiving FOLFOX
2- Investigating the effect of melatonin in reducing the severity of oxaliplatin acute neuropathy
3- Investigating the effect of melatonin in reducing the duration of oxaliplatin acute neuropathy
Design
Randomised, superiority, parallel group trial with blinded outcome assessment phase 3 in 70 ceses and control ( 35 patients in each group).
Settings and conduct
Using the block randomization method, patients are randomly assigned to two groups of 35 people receiving chemotherapy regimen with placebo or the chemotherapy regimen group with melatonin.
One group of patients with colon cancer receiving FOLFOX chemotherapy regimens containing oxaliplatin at a dose of 85 mg/m2 every 2 weeks before the start of chemotherapy will be given 10 mg melatonin tablets daily and another group with the same number of patients will be given placebo daily. and a three-month follow-up of acute neuropathy will be done. In order to check the patient's acceptance of the drug, pills are provided to the patients in each period of chemotherapy treatment.
Participants/Inclusion and exclusion criteria
All patients with history of DM or any type of peripheral nerve injury
Intervention groups
Colon cancer patients under FOLFOX chemotherapy regimen containing oxaliplatin, has been given placebo in the control group and melatonin in intervention group
Main outcome variables
Reducing the incidence of oxaliplatin acute neuropathy ; Reducing the severity of oxaliplatin acute neuropathy ; Reducing the duration of acute neuropathy in colon cancer
General information
Reason for update
Acronym
OIPN
IRCT registration information
IRCT registration number:IRCT20150726023349N5
Registration date:2022-11-28, 1401/09/07
Registration timing:registered_while_recruiting
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Mohsen Esfandbod
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 982 181 631
Email address
sfandbod@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-01-08, 1401/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of melatonin efficacy in prophylaxis of Oxaliplatin induced acute peripheral neuropathy in FOLFOX regimen in patients with colon cancer
Public title
Evaluation of therapeutic effect of melatonin to improve nerve injury due to oxaliplatin
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Street address
Research Institute for Oncology, Hematology and Cell Therapy Tehran University of Medical Sciences, Shariati Hospital, Karegar Ave., Jalal Al-Ahmad, Tehran
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- CTCAEو OSNS, NPSI, EORTC QLQ- C۲۰
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institue Imam khomeini Hospital
Full name of responsible person
Homa Razavidehkordi
Street address
Imam Khomeini Hospital Complex, End of the Keshavarz Blvd., Qarib St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 8083
Fax
+98 21 6658 1593
Email
homa.razavi84@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz BLVD Ghods st. Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 81631
Email
tumspr@tums.ac.ir
Web page address
https://www.tums.ac.ir/
Grant name
Dr Akbar Fotouhi
Grant code / Reference number
1400-3-222-56698
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Homa Razavidehkordi
Position
fellowship of hematology and oncology
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital Complex, End of the Keshavarz Blvd., Qarib St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 8083
Fax
+98 21 6658 1593
Email
homa.razavi84@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohsen Esfandbod
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Hematology
Street address
Imam Khomeini Hospital Complex, End of the Keshavarz Blvd., Qarib St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 8083
Fax
+98 21 6658 1593
Email
sfandbod@sina.tums.ac.ir12345
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Zarrabi
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Imam Khomeini Hospital Complex, End of the Keshavarz Blvd., Qarib St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6692 3688
Fax
+98 21 6692 3688
Email
zarrabi.fa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Informationd are available from January 8, 2022 until September 23,2023
To whom data/document is available
Informations are available for the researchers of academic institutions
Under which criteria data/document could be used
Informations are available for the reaserchers in academic institutions and all physicians and reaserchers in hospitals and medical clinics