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IRCT20150830023823N4 IRCT 2021-07-31 Shiraz University of Medical Sciences Effect of Plantago major leaf gel on prevention of acute radiation dermatitis in breast cancer patients Effect of Plantago major leaf gel compared to placebo on prevention of acute radiation dermatitis in breast cancer patients: A double blind, randomized clinical trial 2021-08-21 anticipated 80 Complete https://irct.ir/trial/56244 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: we use permutation block randomization method with block size of 4. Selected samples based on these blocks are placed in treatment intervention (A) and placebo intervention (B) groups. All possible blocks are arranged as follows: block1:AABB, block 2:ABAB, block 3:ABBA, block 4:BBAA, block 5:BABA, block 6:BAAB.Therefore, according to the sample size (80 subjects) we need 20 blocks. For generation a list of 80 random sequences by permutation block method, we use Random allocation software 2.0. We randomly select these blocks from 1 to 6. Using Random allocation software 2.0, we choose a random number between the numbers 1 to 6. For example, if number 6 is selected as the first block and number 2 as the second block, BAABABAB will be the random sequences according to which people enter the study.We continue this to generate a list of 80 random sequences. Finally, based on this random list, 40 patients will be allocated to group A and 40 patients to group B, Blinding description: The placebo will be made in color, odor, package and other characteristics similar to plantago major gel so that the patients and the researchers can`t distinguish between them. 3 Acute radio dermatitis. Intervention 1: Intervention group: The drug of the intervention group is Plantago major leaf gel. This topical skin gel is made by a pharmacist under the supervision of Shiraz School of Pharmacy.To prepare the topical form of the drug (gel), the Plantago major leaf extract will be added to the gel stand.The gel will also be subjected to microbial control and chemical evaluation. Patients will be instructed to cover the skin of the area under radiation with a thin layer of topical gel twice a day (morning and night). The duration of use is 7 weeks that will continue from the first day of radiation therapy till 2 weeks after the last radiation therapy session. To reduce the effect of bolus, it is recommended that the minimum interval between the use of the gel and the start of each the radiation therapy session be two hours.Patients are also urged to avoid using other topical compounds during treatment. Intervention 2: Control group:placebo that will be applied by control group is the same gel stand used to preparing the plantago major gel. Placebo is also made by a pharmacist under the supervision of Shiraz School of Pharmacy. patients in this group will also be instructed to cover the skin of the area under radiation with a thin layer of topical gel(placebo) twice a day (morning and night). The duration of use is 7 weeks that will continue from the first day of radiation therapy till 2 weeks after the last radiation therapy session.It is also recommended for patients in this group that the minimum interval between the use of the gel and the start of each the radiation therapy session be two hours.Patients are also urged to avoid using other topical compounds during treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is for privacy
public Ali Tavakoli
Zand St, Medical School, Seventh floor, Persian Medicine Department
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences scientific Ali Tavakoli
Zand St, Medical School, Seventh floor, Persian Medicine Department
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 tavakkolia@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with definitive diagnosis of breast cancer who have undergone quadrantectomy treatment. indication of external radiotherapy 18 years old and more 18 years no limit Female previous breast radiotherapy skin tumor rash, ulcer, scar connective tissue disorder diabetes melitus concomitant use of chemotherapy L58.0 Acute radio dermatitis Prevention Prevention Intervention group: The drug of the intervention group is Plantago major leaf gel. This topical skin gel is made by a pharmacist under the supervision of Shiraz School of Pharmacy.To prepare the topical form of the drug (gel), the Plantago major leaf extract will be added to the gel stand.The gel will also be subjected to microbial control and chemical evaluation. Patients will be instructed to cover the skin of the area under radiation with a thin layer of topical gel twice a day (morning and night). The duration of use is 7 weeks that will continue from the first day of radiation therapy till 2 weeks after the last radiation therapy session. To reduce the effect of bolus, it is recommended that the minimum interval between the use of the gel and the start of each the radiation therapy session be two hours.Patients are also urged to avoid using other topical compounds during treatment. Control group:placebo that will be applied by control group is the same gel stand used to preparing the plantago major gel. Placebo is also made by a pharmacist under the supervision of Shiraz School of Pharmacy. patients in this group will also be instructed to cover the skin of the area under radiation with a thin layer of topical gel(placebo) twice a day (morning and night). The duration of use is 7 weeks that will continue from the first day of radiation therapy till 2 weeks after the last radiation therapy session.It is also recommended for patients in this group that the minimum interval between the use of the gel and the start of each the radiation therapy session be two hours.Patients are also urged to avoid using other topical compounds during treatment. Dermatitis grade. Timepoint: weekly for 7 weeks. Method of measurement: observation by physician with Common Terminology Criteria for Adverse Events(CTCAE) version 4. Burning sensation grade. Timepoint: weekly. Method of measurement: Ask the patient with patient symptom scale. Pain. Timepoint: weekly. Method of measurement: Ask the patient with patient symptom scale. Pruritus. Timepoint: weekly. Method of measurement: Ask the patient with patient symptom scale. Shiraz University of Medical Sciences Approved 2021-04-05 Ethics Committee of Shiraz Medical School Zand St. Shiraz Fars Iran (Islamic Republic of)