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IRCT20181208041882N10 IRCT 2023-10-10 Yazd University of Medical Sciences Amantadine in cancer fatigue Evaluation of Amantadine efficacy compared to placebo in the treatment of cancer-related fatigue: a randomized, double-blind clinical trial. 2022-05-09 anticipated 40 Complete https://irct.ir/trial/63367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 40 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 10 blocks of 4 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 40 is in 10 blocks of four in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 40, Blinding description: In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received. The patients in the two groups received the medications in the same packaging. 3 Fatigue due to cancer. Intervention 1: Intervention group: Intervention group: Cancer patients use amantadine hydrochloride 100 mg capsules(Amin company) orally twice a day for 6 weeks. Intervention 2: Control group: Cancer patients use placebo capsules twice a day for 6 weeks. Amantadine placebo is made using capsule pumice purchased from Amin company and by capsule filling machine using cellulose powder. Yes - There is a plan to make this available What will be shared: After nonrecognition, all data can be share When: 6 months after publication To whom: All of researchers Conditions: nothing Where to obtain: Behrooz Heydari email: b.heydari@ssu.ac.ir How to obtain: Request your information by email. The data will be sent after a week. Comments:
public Behrooz Heydari
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences scientific Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Cancer patients who complain of fatigue as a side effect of treatment Patients currently on a chemotherapy regimen are at risk for fatigue no limit no limit Both Patients with a hemoglobin level of less than 10 g / dl Patients with a white blood cell count of less than 3,000 cells / mcl Patients with a platelet count less than 10,000 cells / mcl Patients with a serum creatinine greater than 2 mg / dl Patients whose bilirubin level is 1.5 times normal and their alkaline phosphatase and SGOT levels are more than 3 times normal Patients with melanoma Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Cancer patients use amantadine hydrochloride 100 mg capsules(Amin company) orally twice a day for 6 weeks Control group: Cancer patients use placebo capsules twice a day for 6 weeks. Amantadine placebo is made using capsule pumice purchased from Amin company and by capsule filling machine using cellulose powder. Evaluation of fatigue severity. Timepoint: Weeks 0, 1, 2, 3, 4, 5 and 6. Method of measurement: Questionnaire (Cancer-Related Fatigue Scale). Yazd University of Medical Sciences Approved 2018-02-19 School of Medicine- Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq Yazd Yazd Iran (Islamic Republic of)