]>
IRCT20231226060535N1 IRCT 2023-12-29 Shahid Beheshti University of Medical Sciences royal jelly and chemotherapy Investigating the effect of royal jelly on reducing symptoms of fatigue and weakness associated with chemotherapy in breast cancer 2024-01-10 anticipated 50 Complete https://irct.ir/trial/74641 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used, in which the randomization unit is individual, and random sequence generation software (Random Number Generator software) is used. For concealment, non-transparent sealed envelopes with a random sequence is used . In this method, each random number created is recorded on a card and the cards are placed inside the envelopes in order.In order to maintain the random sequence of the envelopes on the outer surface, the numbering is done in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed, Blinding description: After giving sufficient explanations to the patient about the studied groups, the participants will be assigned to one of the groups without informing them.For this purpose, the capsule with the same shape, size, color and smell as the royal jelly capsule will be used as a placebo. 3 breast cancer. Intervention 1: Intervention group: Each subject in the intervention group will take 1 capsule of royal jelly twice a day after meals for 4 weeks. Intervention 2: Control group: Patients in this group will receive a placebo that will be similar in appearance, shape, color and smell to the Royal Jelly capsules. Patients will consume the capsules twice a day after meals for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet
public Tahere Fallahi
Shahid Chamran highway
Tehran Iran (Islamic Republic of) 4631- 19395 +98 21 2243 9872 taherefallahi52@gmail.com Shahid Beheshti University of Medical Sciences scientific Elnaz Ataei
Shahid Chamran highway
Tehran Iran (Islamic Republic of) 4631- 19395 +98 21 2243 9872 taherefallahi52@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmed diagnosis of breast cancer by laboratory and clinical evidence Hemoglobin > 8 g/dL Hematocrit > 30% SGOT serum level <3 times higher than normal Bilirubin level less than 2 mg/dl Creatinine less than 2mg/dl Normal thyroid test result no limit 60 years Female Having an underlying and chronic active inflammatory disease such as: RA, COPD, unstable cardiovascular disease, lung diseases such as asthma, uncontrolled pain, severe infection, pregnancy, severe depression Simultaneous use of drugs that can affect fatigue Metastatic patients with poor performance C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: Each subject in the intervention group will take 1 capsule of royal jelly twice a day after meals for 4 weeks. Control group: Patients in this group will receive a placebo that will be similar in appearance, shape, color and smell to the Royal Jelly capsules. Patients will consume the capsules twice a day after meals for 4 weeks. Severity of symptoms of fatigue. Timepoint: Measurement of symptoms of fatigue before the intervention and 14 days later. Method of measurement: by Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS) questionnaires. Severity of symptoms of weakness. Timepoint: Measurement of symptoms of weakness before the intervention and 14 days later. Method of measurement: by Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS) questionnaires. Shahid Beheshti University of Medical Sciences Approved 2023-07-25 Ethics Committee of Shahid Beheshti University of Medical Sciences Community Verified icon Shhid Modarres highway Tehran Tehran Iran (Islamic Republic of)