ABSTRACT: Intervention 1: Intervention group: 32 patients will be selected according to the inclusion criteria, using the available sampling method, who come in different work shifts and on different days of the week. After stating the objectives of the study in a meeting and obtaining consent from the patients, the patients enter the study. Demographic information of all participants will be recorded by the researcher. A training session will be held on how to store and use honey and royal jelly. Before receiving the third course of chemotherapy drug, blood parameters test (CBC) will be done and the answers will be recorded in the checklist. The MFI fatigue questionnaire will also be completed by the researcher before the intervention through an interview. Then, in the intervention group, royal jelly prepared from an accredited local apiary approved by the University of Medical Sciences, using cool boxes containing ice and maintaining the cold chain, will be provided to the patients at the time of the visit and they will be asked to finish Carry out the study of royal jelly and keep it in the refrigerator. 10 grams of natural honey containing one gram of royal jelly (10% concentration) will be consumed orally for five days in the morning on an empty stomach in the intervention group. Again, before receiving the next course of chemotherapy, blood parameters will be tested in the aforementioned laboratory. The questionnaire related to the measurement of fatigue will also be completed by the researcher before the start of the new course of chemotherapy through an interview. The data is then analyzed. Intervention 2: Control group: The number of 32 patients will be selected according to the inclusion criteria, using available sampling method, who come in different work shifts and on
Primary outcome(s): Blood cell count includes the count of white blood cells, red blood cells, hemoglobin and platelets, which will be evaluated according to laboratory results. Timepoint: After the end of the second round of chemotherapy, the intervention is carried out using royal jelly and placebo for five days. After two weeks from the end of the intervention, direct evaluation will be done by the researcher. Method of measurement: Counting blood cells using laboratory results (CBC).
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To assign the samples to the study groups randomly, the design of random permutation blocks of two groups with blocks of four will be used, with 32 samples in group A (intervention group) and 32 samples in group B (intervention group) control) will be considered. Then the website https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence. Sealed envelopes will be used for concealment. In this way, based on the sequence of randomly determined blocks, cards with the letters A and B that show the sequence of allocation will be placed inside the envelope. Then, an envelope will be opened for each participant in the study, and based on the card inside the envelope, the participant will be assigned to the control or intervention group, Blinding description: Sealed envelopes will be used for concealment.
