Evaluation of efficacy of Maa-al-shaeer (An Iranian medicine product based on barley seeds) in preventing and reducing the severity of radiotherapy-induced dysuria in prostate cancer patients; a double-blind randomized clinical trial

Evaluation of the efficacy of Maa-al-shaeer in preventing and reducing the severity of radiotherapy-induced dysuria in prostate cancer

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 70 patients. Randomization is done using R software version 4.1.2 and the randomization list generated using R software will be used.

Prostate cancer patients candidates for radiotherapy (in the radiotherapy center of Shohada-e-Tajrish Hospital), without the exclusion criteria, will be included in the study and assigned to the intervention or control group randomly. The study is double-blind, and patients, healthcare providers, researchers, and analysts are all blinded.

Inclusion criteria: 1. Over 18 years old 2. Prostate cancer 3. Candidate for radiation therapy 4. Consciousness Criteria for not entering the study: 1. Unconsciousness or unable to report the dysuria 2. Urine catheter 3. Urine analysis test with infection evidence 4. Diabetes Mellitus 5. Dysuria 6. History of drug sensitivity 7. Metastasis 8. Chemotherapy at the same time 9. Hematuria 10. Severe cardiovascular, pulmonary, hepatic, and kidney disease needs to be treated 11. Not participating in the study

The participants, twice a day, each time, a measure (equivalent to 7.5 cc) of powder (Maa-al-shaeer in the intervention group or placebo in the control group) dissolve in a glass of water and consume it. The duration of using the drug or placebo is 4 weeks from the beginning of radiotheraphy.

Dysuria, Quality of life, The number of phenazopyridine tablets which was taken, Treatment satisfaction (secondary outcome)

Simple Randomization. Randomization is done using R software version 4.1.2, and we will use the randomization list generated using R software. In order to conduct this study, first, using the available method, patients who meet the conditions for entering the study, after completing the consent form, will enter the study until the number of calculated samples is complete. In the next step, in order to homogenize and control the background and confounding variables in the intervention and control groups, the block randomization method will be used to assign patients to two groups. For this purpose and according to the calculated sample size, 5 blocks of 14 blocks will be generated using R software. In each block, the interventions are randomly assigned to people with a ratio of 1:1. Since the shape of the drug and the placebo are completely similar and the labels on the cans of the interventions (drug or placebo) are prepared by a statistician (using R software) and sticked in the pharmaceutical laboratory, so, the participants and the researcher are all blind to it.

Double Blind. In this study, the barley product is prepared in the form of powder and is packed in a can and coded after putting a label. Placebo is also prepared with the same particle size and color as the drug in the same packaging as the drug and is coded. Therefore, until the encoding, it is not possible for the participants, principle investigator, healthcare providers, data collectors, outcome assessors, manuscript writers to distinguish the drug from the placebo.

The study has not yet started, after the study is completed a decision will be made about sharing the participants' non-identifiable personal data.