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.
Design
Clinical trial with control group and parallel multi-blind groups randomized with 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 30 to 60 years of age and the presence of cancer-induced fatigue during chemotherapy
Intervention groups
Selenium 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
Acronym
IRCT registration information
IRCT registration number:IRCT20210825052293N1
Registration date:2021-10-03, 1400/07/11
Registration timing:prospective
Last update:2021-10-03, 1400/07/11
Update count:2
Registration date
2021-10-03, 1400/07/11
Registrant information
Name
alireza mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 2744
Email address
alireza.mansory@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-08-23, 1401/06/01
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:
30 to 60 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 30 years old to 60 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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method and generating random values between zero and one in SPSS software. Random values less than or equal to 0.5 and greater than 0.5 are assigned to group A and B respectively. Then an independent individual from research team, encodes 70 envelopes (based on the codes obtained from mentioned randomization method), so a list of codes is provided. In the envelope, based on the mentioned method, either of "new treatment" or "placebo" options will be written and according to the order of eligible patients, the envelope will be given to the patients in the clinic to deliver it to an oncologist. Based on patients' grouping, the therapist provides necessary prescriptions and advices for each patient. In the meantime, the researcher remains unaware of the group to which each patients belongs.
Blinding (investigator's opinion)
Double 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Sohrevardi St-baghziar st-Dolphin2 Apartment
City
esfahan
Province
Isfehan
Postal code
8177773095
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, 3 weeks, 6 weeks
Method of measurement
Multivariable questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients take 200 ug selenium capsules under the brand name of Selenium Alpha manufactured by Alpha Vitamin Laboratories, Inc once daily for 3 weeks and then fill in the fatigue questionnaire. After filling out the questionnare patients take the mentioned supplement for another 3 weeks (a total of 6 weeks of supplemention is performed). Finally, patients fill in the questionnaire once more and the results are analyzed using SPSS software version 10.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients take 1 capsule of placebo once daily for 3 weeks and then fill in the questionnaire of fatigue. After an interval of 1 week, patients take 1 capsule of placebo once daily for another 3 weeks (a total of 6 weeks of supplemention is performed). Finally patients fill in the questionnaire once more and results are analyzed using SPSS software version 10.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra clinics
Full name of responsible person
کلینیک الزهرا(شیمی درمانی)
Street address
Sheikh Mofid Street
City
esfahan
Province
Isfehan
Postal code
8163743787
Phone
+98 31 3776 2744
Email
Ali_hajigholami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mrs Shaghayegh Haghjooye Javaanmard
Street address
Hezar Jarib Street-Vice Chancellery of Research and Technology
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
Ali_hajigholami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?