Protocol summary
-
Study aim
-
The aim of this study was to evaluate the effect of selenium supplementation on cancer-related fatigue in cancer patients undergoing chemotherapy and to compare it with the placebo effect.
-
Design
-
A clinical trial with 70 patients, featuring a control group, parallel groups, and a triple-blind randomized design using a random number table.
-
Settings and conduct
-
Based on previous studies on the effects of pharmacological intervention on cancer-related fatigue in chemotherapy clinics affiliated to Isfahan University of Medical Sciences. Blinding the groups of clinicians, researchers and data analysts.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria were 18 to 80 years of age and the presence of cancer-induced fatigue during chemotherapy
-
Intervention groups
-
Seleniumplus supplementation in intervention group and placebo administration in control group
-
Main outcome variables
-
The main outcome is the improvement of various parameters related to fatigue including physical weakness, etc. in patients.
General information
-
Reason for update
-
Subject: Request for Clinical Trial Information Update
Dear Sir/Madam,
I would like to request the following changes to the registered information of the clinical trial. The reasons for these changes are as follows:
Participant Age Range:
Please update the participant age range from "30-60 years" to "18-80 years."
Reason: This change aims to broaden the scope of the study and achieve more comprehensive results by including a more diverse age group.
Duration of Supplementation:
Please adjust the supplementation duration from "6 weeks" to "4 weeks."
Reason: This change is due to the shorter chemotherapy intervals for patients, making a 4-week supplementation period more accessible.
Type of Supplement:
In the original registration, only "selenium" was mentioned. However, the placebo was prepared with vitamins A, C, and E. If this adjustment had not been made, the control group would have been deprived of treatment, which is against ethical standards.
Currently, the treatment group is receiving "Selenium Plus," while the control group is receiving "Selenium Plus without Selenium." This ensures that both groups are in similar conditions, with the only difference being the presence or absence of selenium.
To enhance the credibility of the study, a triple-blind method will be implemented. In this approach, neither the participants, researchers, nor analysts will know the type of treatment being administered, which helps to reduce bias and increase the validity of the results.
Thank you for your attention and cooperation.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210825052293N1
Registration date:
2021-10-03, 1400/07/11
Registration timing:
prospective
Last update:
2025-07-19, 1404/04/28
Update count:
2
-
Registration date
-
2021-10-03, 1400/07/11
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-10-23, 1400/08/01
-
Expected recruitment end date
-
2024-10-22, 1403/08/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Evaluation of the effect of selenium supplemention on cancer-related fatigue in outpatient cancer patients and comparison of it with placebo effect in control group
-
Public title
-
The effect of selenium on cancer related-fatigue
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
18 to 80 years of age
To be able to read and write
Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist
Not having another treatment regimen that has healing effect on fatigue
To have cancer-related fatigue and score of 40 and above in fatigue questionnaire
To tolerate oral medication
To cooperate and agree with the study
Exclusion criteria:
Patients with known depression undergoing treatment
Having anemia
Having a disease that prevents patient from continuing participation in study
When more than 20% of the questionnaire has not been completed
Pregnancy and lactation
Renal failure
Taking medications such as baloxavir, marboxil, deferiprone, cabotegravir, bisphosphonate derivatives, bictegravir, dolutegravir, eltrombopag, trientine, raltegravir, penicillamine, elvitegravir
Known allergy to selenium
Hypothyroidism
Skin cancer and individulas at high risk for developing squamous cell carcinoma
-
Age
-
From 18 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
76
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Group Allocation and Coding:
In this clinical trial, the drugs (Selenium Plus and Selenium Plus without Selenium) were divided and coded into two groups, "A" and "B," by a pharmacology professor acting as the supervisor. This supervisor is also blinded to the contents of each group to prevent any potential bias.
Administration of the Drugs:
Neither the participants nor the researchers know which group receives which treatment. As such, the patients are unaware whether they are receiving Selenium Plus or the placebo (Selenium Plus without Selenium), and the doctors administering the treatment are similarly blinded to the type of drug being given.
Data Analysis:
Upon completion of the study and data collection, the statistical analysis is carried out by analysts who are also unaware of which group received the actual drug and which received the placebo. This ensures that the statistical results are free from bias.
Final Unblinding:
After the statistical analysis is completed, the pharmacist supervisor, who holds the group codes, reveals the information. At this stage, it is disclosed which group received Selenium Plus and which received Selenium Plus without Selenium.
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
The secretary introduced the patients to the oncologist using randomized grouping and the oncologist provided treatments for each patient based on their group. The researcher, in cooperation with the oncologist, supervised the patient's use of the drug. Data available from questionnaires completed by the patients, were analyzed by a statistician specialist with respect to the confidentiality of the grouping.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-05-08, 1400/02/18
-
Ethics committee reference number
-
IR.MUI.MED.REC.1400.098
Health conditions studied
1
-
Description of health condition studied
-
Cancer-related fatigue
-
ICD-10 code
-
R53.0
-
ICD-10 code description
-
Neoplasm-related fatigue
Primary outcomes
1
-
Description
-
Cancer-related fatigue
-
Timepoint
-
Zero, 2 weeks, 4 weeks
-
Method of measurement
-
Multivariable questionnaire
Intervention groups
1
-
Description
-
Intervention Group: In this group, patients will take one 200 µg capsule of Selenium Plus once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the capsule for an additional 2 weeks, totaling 4 weeks of treatment. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control Group: In this group, patients will take a placebo once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the placebo for an additional 2 weeks, totaling 4 weeks. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be 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
-
All data in the study except for personal data can be shared.
-
When the data will become available and for how long
-
The start of the access period is 6 months after the results are printed.
-
To whom data/document is available
-
At the current stage,the results will be available to researchers at university institutes.
-
Under which criteria data/document could be used
-
In terms of data analysis and analysis for academic researchers and use in later studies.
-
From where data/document is obtainable
-
School of social medicine,Isfahan Ali_hajigholami@yahoo.com
-
What processes are involved for a request to access data/document
-
By submitting a written request to the director of the Social Medicine School, Isfahan
-
Comments
-