Investigating the effect of royal jelly on reducing symptoms of fatigue and weakness associated with chemotherapy in breast cancer

Determining the effect of royal jelly on reducing symptoms of fatigue and weakness associated with chemotherapy in breast cancer

A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 50 patients. Using kitset.ir for randomization

Study patients in Shahid Modares Hospital, Tehran, in the intervention group will receive 1 oral capsule of royal jelly 2 times a day and in the control group, placebo for 2 weeks. Only the patients will be blinded and will not know about the study groups.

Inclusion criteria: age below 60 years, confirmed diagnosis of breast cancer, hemoglobin > 8 g/dL, hematocrit > 30%, SGOT serum level < 3 times higher than normal, bilirubin < 2 mg/dl, creatinine < 2 mg /dl and normal thyroid test result Exclusion criteria: suffering from an underlying and chronic active inflammatory disease, simultaneous use of drugs affecting fatigue, metastatic patients with poor performance

Each subject in the intervention group will take 1 oral capsule of royal jelly 2 times a day with water, and the control group will receive a placebo that will be similar in appearance, shape, color and smell to royal gel capsules. Patients will consume these capsules for 4 weeks.

Severity of weakness and fatigue after chemotherapy.

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.

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.