Determining the effectiveness of amantadine compared to placebo in the treatment of cancer-related fatigue
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 40 patients. The the block random allocation method was used for randomization.
Settings and conduct
This project was carried out at Shahid Sadoughi Hospital in Yazd. Patients in two groups of 20 use amantadine capsule or placebo twice daily for 6 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer patients who complain of fatigue as a side effect of treatment, Patients currently on a chemotherapy regimen are at risk for fatigue
Exclusion criteria: 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.
Intervention groups
In order to evaluate the effectiveness of amantadine in cancer fatigue, a group of 20 people is given amantadine and a group of 20 people is given a placebo.
Main outcome variables
Fatigue intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N10
Registration date:2023-10-10, 1402/07/18
Registration timing:retrospective
Last update:2023-10-10, 1402/07/18
Update count:0
Registration date
2023-10-10, 1402/07/18
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-09, 1401/02/19
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Amantadine efficacy compared to placebo in the treatment of cancer-related fatigue: a randomized, double-blind clinical trial.
Public title
Amantadine in cancer fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients who complain of fatigue as a side effect of treatment
Patients currently on a chemotherapy regimen are at risk for fatigue
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.197
Health conditions studied
1
Description of health condition studied
Fatigue due to cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of fatigue severity
Timepoint
Weeks 0, 1, 2, 3, 4, 5 and 6
Method of measurement
Questionnaire (Cancer-Related Fatigue Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Cancer patients use amantadine hydrochloride 100 mg capsules(Amin company) orally twice a day for 6 weeks
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Hasanali vahedian
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh, Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
امیرهوشنگ مهرپرور
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
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
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.