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IRCT20150830023823N5 IRCT 2026-01-09 Shiraz University of Medical Sciences Effect of a combined topical formulation of Plantago major leafs and Rosa damascena oil on prevention of acute radiation dermatitis in breast cancer patients Investigating the effect of a combined topical formulation of Plantago major leafs and Rosa damascena oil on prevention of acute radiation dermatitis in breast cancer patients- A randomized double-blind placebo-controlled clinical trial 2026-02-20 anticipated 100 Complete https://irct.ir/trial/88231 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization In this study, we use permutation block randomization method with blocks of size 4 and an allocation ratio of 1:1. Since we have two interventions, labeled A and B, each block consist of one of the six possible four-tuple permutations of A and B. The different permutations are assigned to the numbers 1 to 6 as follows: 1 – AABB 2 – ABAB 3 – ABBA 4 – BBAA 5 – BABA 6 – BAAB Using a random number table, we extract numbers sequentially. Whenever a number between 1 and 6 appears, the corresponding block assigned to that number is selected. If the numbers 0, 7, 8, or 9 appear, they are ignored. We need 25 blocks of size 4 according to the sample size (100 subjects). Therefore, we continue this process until a list of 100 random sequences is generated. Finally, based on this random list, 50 patients will be allocated to group A and 50 patients to group B, Blinding description: The placebo is made to be similar in color, odor, packaging, and other characteristics to the Combined Topical Formulation of Plantago major leafs and Rosa damascena Oil so that patients and researchers cannot distinguish between them. 3 Acute radiodermatitis. Intervention 1: Intervention group:The drug of the intervention group is a combined topical formulation of Plantago major leafs extract and Rosa damascena oil that is made by the Knowledge-Based Pharmaceutical Chemists Company (Daneshkim) in Shiraz, and is then sent to the laboratory of the Faculty of Pharmacy for microbial control and chemical evaluation tests. Patients will be instructed to cover the skin of the radiation-treated area with a thin layer of the topical formulation twice daily (morning and evening). The duration of use is 7 weeks, starting on the first day of radiation therapy and continuing until two weeks after the last radiation therapy session. To reduce the bolus effect, it is recommended that there be at least a two-hour interval between the use of the topical formulation and the start of the radiotherapy session. Patients are also urged to avoid the use of other topical compounds during treatment. Intervention 2: Control group: The placebo is prepared with the same materials used to make the drug except for the Plantago major leafs extract and Rosa damascena oil. The placebo is also made by the Knowledge-Based Pharmaceutical Chemists Company (Danshkim) in Shiraz. Patients will be instructed to cover the skin of the radiation-treated area with a thin layer of the topical formulation( placebo) twice daily (morning and evening). The duration of use is 7 weeks, starting on the first day of radiation therapy and continuing until two weeks after the last radiation therapy session. To reduce the bolus effect, it is recommended that there be at least a two-hour interval between the use of the formulation and the start of the radiotherapy session. Patients are also urged to avoid the use of 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 a definitive diagnosis of breast cancer who have undergone quadrantectomy and are scheduled to receive a course of external radiotherapy to the chest wall 18 years old and more 18 years no limit Female Previous history of radiotherapy to the chest wall A skin tumor, rash, ulcer, or unhealed scar in the area under radiation History of connective tissue disorders History of diabetes mellitus Concomitant use of chemotherapy L58.0 Acute radiodermatitis Prevention Prevention Intervention group:The drug of the intervention group is a combined topical formulation of Plantago major leafs extract and Rosa damascena oil that is made by the Knowledge-Based Pharmaceutical Chemists Company (Daneshkim) in Shiraz, and is then sent to the laboratory of the Faculty of Pharmacy for microbial control and chemical evaluation tests. Patients will be instructed to cover the skin of the radiation-treated area with a thin layer of the topical formulation twice daily (morning and evening). The duration of use is 7 weeks, starting on the first day of radiation therapy and continuing until two weeks after the last radiation therapy session. To reduce the bolus effect, it is recommended that there be at least a two-hour interval between the use of the topical formulation and the start of the radiotherapy session. Patients are also urged to avoid the use of other topical compounds during treatment. Control group: The placebo is prepared with the same materials used to make the drug except for the Plantago major leafs extract and Rosa damascena oil. The placebo is also made by the Knowledge-Based Pharmaceutical Chemists Company (Danshkim) in Shiraz. Patients will be instructed to cover the skin of the radiation-treated area with a thin layer of the topical formulation( placebo) twice daily (morning and evening). The duration of use is 7 weeks, starting on the first day of radiation therapy and continuing until two weeks after the last radiation therapy session. To reduce the bolus effect, it is recommended that there be at least a two-hour interval between the use of the formulation and the start of the radiotherapy session. Patients are also urged to avoid the use of other topical compounds during treatment. Incidence and the severity of dermatitis. Timepoint: weekly for 7 week. Method of measurement: Physician observation with Common Terminology criteria for Adverse Events (CTCAE) version 6. Burning sensation grade. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale. Pain severity. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale. Pruritus severity. Timepoint: Weekly. Method of measurement: Questioning the patient with the Patient Symptom Scale. Shiraz University of Medical Sciences Approved 2025-12-20 Ethics Committee of Shiraz Medical School Zand St. shiraz Fars Iran (Islamic Republic of)