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IRCT20230328057779N1 IRCT 2023-05-29 Zanjan University of Medical Sciences Investigating the effect of royal jelly on blood cell count and fatigue in cancer patients undergoing chemotherapy. Investigating the effect of royal jelly on blood cell count and fatigue in cancer patients undergoing chemotherapy. 2023-06-20 anticipated 64 Complete https://irct.ir/trial/70361 interventional 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. 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. N/A Condition 1: Stomach Cancer. Condition 2: Esophagus cancer. Condition 3: Malignant neoplasm of small intestine. Condition 4: Malignant neoplasm of colon. Condition 5: Malignant neoplasm of rectum. Condition 6: Malignant neoplasm of liver and intrahepatic bile ducts. Condition 7: Malignant neoplasm of bronchus and lung. Condition 8: Malignant neoplasm of heart, mediastinum and pleura. Condition 9: Breast cancer. 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 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 control group, honey (placebo) prepared from an authentic local bee farm approved by the University of Medical Sciences, using cool boxes containing ice and maintaining the cold chain, will be provided to the patients during the visit and they will be asked to Keep the honey (placebo) in the refrigerator until the end of the study. 10 grams of natural honey will be consumed orally for five days in the morning fasting in the Control 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. Yes - There is a plan to make this available What will be shared: The data related to the age and gender of the study participants will be published after the end of the study. When: 21/12/2023 To whom: Researchers working in academic and scientific institutions. Conditions: In conducting scientific research Where to obtain: Mr. Alireza Ghane 09375780121 alirezagh2233175@gmail.com Dr. Nasrin Hanifi 09123422431 nasrinhanifi@zums.ac.ir How to obtain: A confirmation form from a university or scientific institute based on research work should be submitted. Comments:
public Alireza Ghane
Faculty of Nursing, Zanjan University of Medical Sciences
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8318 alirezagh2233175@gmail.com Zanjan University of Medical Sciences scientific Nasrin Hanifi
Zanjan University of Medical Sciences
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8336 nasrinhanifi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Cancer diagnosis recorded in the patient`s medical records Receiving at least two courses of chemotherapy drugs. Receiving drugs that suppress the bone marrow and cause pancytopenia with the approval and supervision of a respected oncology doctor. Age above 18 years. Consent to participate in the study. Physical and hemodynamics stability. 18 years 60 years Both Having a history of cardiovascular diseases, asthma and diabetes. Having any major disabling medical and psychiatric conditions that would interfere with the evaluation. Having a history of allergy to honey and honey products. Age over 60 years C16 C15 C17 C18 C20 C22 C34 C38 C50 Malignant neoplasm of stomach Malignant neoplasm of esophagus Malignant neoplasm of small intestine Malignant neoplasm of colon Malignant neoplasm of rectum Malignant neoplasm of liver and intrahepatic bile ducts Malignant neoplasm of bronchus and lung Malignant neoplasm of heart, mediastinum and pleura Malignant neoplasm of breast Rehabilitation Placebo 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. 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 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 control group, honey (placebo) prepared from an authentic local bee farm approved by the University of Medical Sciences, using cool boxes containing ice and maintaining the cold chain, will be provided to the patients during the visit and they will be asked to Keep the honey (placebo) in the refrigerator until the end of the study. 10 grams of natural honey will be consumed orally for five days in the morning fasting in the Control 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. 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). Fatigue is evaluated using the Smet's Multidimensional Fatigue Assessment Questionnaire, which ranges from 20 to 100, and a higher score indicates more fatigue. 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: assessing fatigue using a 20-item questionnaire, Smet's multidimensional measurement of fatigue (Multidimensional Fatigue Inventory). Zanjan University of Medical Sciences Approved 2023-03-29 Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)