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

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.

A clinical trial with 70 patients, featuring a control group, parallel groups, and a triple-blind randomized design using a random number table.

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.

Inclusion criteria were 18 to 80 years of age and the presence of cancer-induced fatigue during chemotherapy

Seleniumplus supplementation in intervention group and placebo administration in control group

The main outcome is the improvement of various parameters related to fatigue including physical weakness, etc. in patients.

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.

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.

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.

All data in the study except for personal data can be shared.

The start of the access period is 6 months after the results are printed.

At the current stage,the results will be available to researchers at university institutes.

In terms of data analysis and analysis for academic researchers and use in later studies.

School of social medicine,Isfahan Ali_hajigholami@yahoo.com

By submitting a written request to the director of the Social Medicine School, Isfahan