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

To compare the effect of selenium-enriched saccharomyces cerevisiae and sodium selenite on the improvement of clinical-stage, limb circumference, skinfold index, feeling of heaviness, quality of life, and inflammatory and oxidative stress biomarkers in patients with breast cancer-related lymphedema

The controlled clinical trial, with two parallel arms, triple-blind, randomized, phase 3 on 50 patients. RAS (Random Allocation Software) will be used for randomization

The eligible women who suffer from breast cancer-related lymphedema referring to the oncology clinics of Tabriz educational hospitals will be selected through convenience sampling. Participants will be randomly assigned to two groups (1:1) of organic selenium supplements and placebo which will be similar in shape, color, and weight. The researcher, participant, data analyst, and outcome assessor will be blind.

Inclusion criteria: The first or second stage of Breast Cance-Related Lymphedema (BCRL), unilateral arm lymphedema, body mass index between 18.5 to 30. Exclusion criteria: The presence of bilateral lymphedema, the existence of known metastasis, the existence of diseases leading to swelling such as heart and kidney failure, the current consumption of selenium or compounds containing it, any known allergy to yeast.

The first group will receive one 500 mg capsule per day containing 200, 300, and 400 micrograms of selenium-enriched yeast for the first, second, and third 20 days daily and be taken with a meal for 3 months. The second group will receive 500 mg placebo capsules containing yeast similar to the first group. The placebo will be taken with the same prescription as the selenium capsule

Changes in mean limb circumference; Skinfold index; Mean score of quality of life after intervention

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.

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.

Data on the main outcome will be published

Six months after printing the results

Researchers at institutions have access to data

In order to help scientific progress in the field of research

farshbafa@tbzmed.ac.ir

Scientific approval of the applicant by Tabriz University of Medical Sciences