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IRCT20201219049763N1 IRCT 2021-06-08 Iranian academic center for education culture and research Assessing the effectiveness of topical peppermint cream and orally ingestible peppermint oxymel mouthwash on halitosis and vomiting of breast cancer patients during chemotherapy A clinical trial to assess the effectiveness of antiemetic and anti-halitosis topical peppermint cream and orally ingestible peppermint oxymel mouthwash in breast cancer patients during chemotherapy 2021-06-20 anticipated 225 Complete https://irct.ir/trial/53233 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by assigning the subjects under study to 6 blocks. In each block, individuals are randomly assigned to one of the groups using topical peppermint, peppermint oral mouthwash, and control in a ratio of 2-2-2. The order of random assignment of individuals to the study groups in each block is kept in sealed envelopes, and the individual who has nothing to do with measuring the outcomes is responsible for assigning individuals to different treatments, Blinding description: Due to the difference in the combination of the two drugs used, it is not possible to blind the participant and clinical care. Also, in order to follow the patients and evaluate the effectiveness and side effects of the drug, it is necessary to emphasize the adherence to the drug, so the evaluator cannot be blind. In this case, it is only possible to blind the researcher and analyst. 3 Breast cancer patients treated with chemotherapy drugs. Intervention 1: Intervention group one: In addition to taking the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone, patients use mint serpentine mouthwash.Its ingredients are 5% water, 5% honey and 1% grape vinegar, to which 2% peppermint extract is added. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, 2 tablespoons (equivalent to 10 ml) of mouthwash mixed with 6 tablespoons of water are mixed in the mouth and then swallowed. Intervention 2: Patients use topical peppermint cream in addition to the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone.The ratio of its components is Cetostearyl alcohol 8g, Cetomacrogol 2g, poly ethylen glycol 6g , propylen glycol 6g, ethanol 10g, distilled water 60cc, peppermint essential oil 1cc. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, rub 1 cm on the forehead and 0.5 cm on the back of each ear. Intervention 3: Control group: Patients taking only the usual anti-nausea and vomiting medications Aprepitant and Dexamethasone. 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 There is no more information
public Alireza Madjid Ansari
No. 146 , South Gandhi Ave , Gandhi Square
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6208 majidansari@acecr.ac.ir Iranian academic center for education culture and research scientific Alireza Madjid Ansari
No. 146 , South Gandhi Ave , Gandhi Square
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6208 majidansari@acecr.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Iran (Islamic Republic of) No history of nausea and vomiting for other reasons Full consciousness Literacy Complete satisfaction in participating in this project Breast cancer, ac4T4 chemotherapy regimen, taking anti-nausea and vomiting drugs Aprepitant and Dexamethasone No history of allergies Medicinal plants No history of respiratory diseases, asthma, diabetes and autoimmune diseases no limit no limit Female Eliminate patients who use medications or treatments other than those prescribed during the study to reduce nausea and vomiting Patients who forget to use the product and mouthwash three or more times in a row C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Other Intervention group one: In addition to taking the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone, patients use mint serpentine mouthwash.Its ingredients are 5% water, 5% honey and 1% grape vinegar, to which 2% peppermint extract is added. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, 2 tablespoons (equivalent to 10 ml) of mouthwash mixed with 6 tablespoons of water are mixed in the mouth and then swallowed. Patients use topical peppermint cream in addition to the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone.The ratio of its components is Cetostearyl alcohol 8g, Cetomacrogol 2g, poly ethylen glycol 6g , propylen glycol 6g, ethanol 10g, distilled water 60cc, peppermint essential oil 1cc. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, rub 1 cm on the forehead and 0.5 cm on the back of each ear. Control group: Patients taking only the usual anti-nausea and vomiting medications Aprepitant and Dexamethasone. Nausea score in questionnaires. Timepoint: At the beginning of the study, every day based on the Daily questionnaire, every 14 days based on the Rhodes questionnaire. Method of measurement: Daily questionnaire and Rhodes questionnaire. Halitosis scores on questionnaires. Timepoint: At the beginning of the study, every day based on the Daily questionnaire, every 14 days based on the Rhodes questionnaire. Method of measurement: Daily questionnaire and Rhodes questionnaire. Iranian academic center for education culture and research Approved 2021-01-13 Motamed Cancer Institute Gandhi South Tehran Tehran Iran (Islamic Republic of)