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IRCT20131009014957N12 IRCT 2022-04-07 Tabriz University of Medical Sciences Effect of organic selenium on the treatment of breast cancer-related lymphedema The effect of selenium-enriched saccharomyces cerevisiae on the improvement of clinical-stage, limb circumference, skinfold index, sense of heaviness, quality of life, and inflammatory and oxidative stress biomarkers in patients with breast cancer-related lymphedema: A triple-blind randomized controlled trial 2022-05-21 anticipated 50 Complete https://irct.ir/trial/62202 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible women will be assigned into two groups of selenium-enriched yeast supplements or placebo using a randomized blocking method with the 4 and 6 sized blocks and a 1: 1 allocation ratio. The allocation sequence will be generated by the researcher through RAS (Random Allocation Software). The medicines and placebo will be placed in a container. Containers will be assigned numbers from 1 to 50. They will be the same shape, closed, opaque, and contain 60 capsules, and their preparation will be done based on the sequence allocation by the person not involved in the research, Blinding description: The first group will receive one 500 mg capsule of selenium-enriched yeast (containing 400-300-200 micrograms of organic selenium) daily, and the second group will receive a placebo capsule (containing 500 mg of yeast) that will be the same shape, color, and weight. participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded. 3 Breast Cancer-Related Lymph edema. Intervention 1: Intervention group: They will take one 500 mg S.cerevisiae yeast capsule per day containing 400, 300, and 200 micrograms of organic selenium for the first, second, and third 20 days for 60 days in total orally with meals. Organic selenium will be produced at the Nutrition Research Center. Intervention 2: Control group: They will take one 500 mg oral capsule containing S. cerevisiae yeast per day for 60 days, which will be similar in shape, color, and weight to selenium-containing capsules. and will be produced at the Nutrition Research Center. Yes - There is a plan to make this available What will be shared: Data on the main outcome will be published When: Six months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of the applicant by Tabriz University of Medical Sciences Comments:
public Azizeh Farshbaf-Khalili
Physical Medicine and Rehabilitation Research Center Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3337 1134 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Bina Eftekharsadat
Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 33371134 binasadat@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The first or second stage of breast cancer-related lymphedema Unilateral arm lymphedema Body mass index between 18.5 to 30 15 years no limit Female The presence of bilateral lymphedema The existence of known metastasis The existence of diseases leading to edema such as heart and kidney failure. I 97 Postprocedural disorders of circulatory system, not elsewhere classified Treatment - Drugs Placebo Intervention group: They will take one 500 mg S.cerevisiae yeast capsule per day containing 400, 300, and 200 micrograms of organic selenium for the first, second, and third 20 days for 60 days in total orally with meals. Organic selenium will be produced at the Nutrition Research Center Control group: They will take one 500 mg oral capsule containing S. cerevisiae yeast per day for 60 days, which will be similar in shape, color, and weight to selenium-containing capsules. and will be produced at the Nutrition Research Center Limb circumference (arm, forearm, wrist). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Tape meter. Skinfold thickness. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using the specified formula. Quality of life score. Timepoint: Baseline and 60 days after the intervention. Method of measurement: WHOQOL-BREF standard quality of life questionnaire. Clinical stage of lymphedema. Timepoint: Baseline and 60 days after the intervention. Method of measurement: According to the staging system of International Society of Lymphology. Heaviness and tiredness feeling. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Numerical pain rating scale (NRS). Serum inflammatory factors (High-sensitivity C-reactive Protein, Interleukin 6). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using ELISA method and Immunoturbodimetry. Oxidative stress biomarkers (Malondialdehyde and Glutathione peroxidase). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) method. The frequency of probable side effects resulting from supplement use such as nausea, diarrhea, and stomach ache. Timepoint: During and after the intervention. Method of measurement: Questionnaire. Satisfaction with medication. Timepoint: During and after the intervention. Method of measurement: Satisfaction rate questionnaire. Tabriz University of Medical Sciences Approved 2022-02-02 The Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Floor 3, No 2 Central Building, Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)