study of effectiveness of Duloxetine in improving symptoms of chemotherapy induced polyneuropathy by vincristine in children with cancer in Mofid Hospital in 1403.

effectiveness of Duloxetine in improving the symptoms of polyneuropathy caused by vincristine

A randomized clinical trial with a control group and a three-way blind on 56 cancer patients referred to Mofid Hospital Clinic.

At first, a SNAP, CMAP of the median nerve and lateral SURAL, DPN will be taken from patients who refer to the children's oncology clinic, who have been 8 weeks or 4 doses of vincristine. And, the PM-TNs questionnaire is completed. Then, if the neuropathy is confirmed, the patients are divided into two groups: placebo and intervention and receive the drug (the placebo and intervention are 20 mg once a day and after a week the dose is increased to 40 mg a day) . After two months of receiving the placebo or intervention, the patient is evaluated in terms of muscle nerve strip and pm-TNS and the side effects of the drug. It should be noted that according to ethical considerations, patients of both groups are subjected to exercise therapy for polyneuropathy.

for entering : Sign the informed consent Age between 5-18 years Cancer patients treated with vincristine Patients who have clinical symptoms of CIPN according to the clinical diagnosis of the oncologist for not entering: present other underlying polyneuropathies Cognitive impairment taking the following drugs: nifedipine, cyclosporine, carbamazepine, phenytoin, HCSF, vit E, B6, B12, omega-3 and herbal medicines

Patients in the intervention group will be treated with 20 mg Duloxetine drug in the first week and after one week the dose will be increased to 40 mg per day for two months. And the patients who are in the placebo group will be treated with a placebo in exactly the same way and packaging and instructions.

- Evaluation of changes in polyneuropathy symptoms caused by vincristine with Duloxetine

In this clinical trial study, 56 patients diagnosed with polyneuropathy caused by vincristine will be included in the study randomly. Block randomization method will be used for random allocation of people in the studied groups (intervention group and comparison group). In this method, blocks of 4 (including two people in the intervention group and two people in the comparison group) will be used with a ratio of 1:1. To generate random sequences, PASS software will be used. For concealment, random allocation concealment method will be used. In this way, the code table generated by the software will be given to the pharmacologist, and the cans containing drugs and placebo will be given to them in It will be found that there is a code on each can based on the master table, it will be determined what the drug content is. An example of the produced table is as follows: Sequence Subject ID Factor 1 Block Treatment 1 101 Level 1 1 A 2 102 Level 1 1 B 3 103 Level 1 2 B 4 104 Level 1 2 A 5 105 Level 1 3 B 6 106 Level 1 3 A 7 107 Level 1 4 B 8 108 Level 1 4 B 9 109 Level 1 4 A 10 110 Level 1 4 A

drug and placebo, are coded by a person outside the study and placed in separate packages and given to patients who are block randomization based on the table of random numbers, and the patients, the main researcher (doctors) and The person analyzing the statistical data was blinded to their assignment in the study.

All data can be shared after de-identifying individuals

Access period starts after registration of results

The data will be available to researchers working in academic and scientific institutions

Only in order to achieve a treatment protocol for children with cancer and with a larger sample size

email:Dr.atefeh1374@gmail.com

After reviewing the request via email and providing the applicant's goals for the new study