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

Determining 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, parallel-design controlled clinical trial in 100 breast cancer patients

The study site is the Radiation Therapy Center of Namazi Hospital, Shiraz. Blinding will be provided to patients and the evaluating medical staff. The treatment duration is 7 weeks. Patients will be followed up and visited weekly for the duration of radiation therapy and two weeks after the last radiation therapy session.

inclusion criteria: Patients (≥18 years) with a confirmed diagnosis of breast cancer who require external radiotherapy. Exclusion criteria:: 1-Prior chest wall radiation 2-Skin tumors, rashes, ulcers, or unhealed scars in the radiation field 3-Hx of connective tissue disease 4-Hx of diabetes 5-Concomitant use of chemotherapy

100 eligible patients will be randomly assigned to two groups. The intervention group will receive a topical formulation of Plantago major and rose‑oil, and the control group will receive a placebo. Patients in both groups will be instructed to cover the area under radiation with a thin layer of topical agent twice a day from the first day of radiotherapy until two weeks after the final session.

Reducing the incidence & severity of acute radiation-induced dermatitis in patients with breast cancer

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.

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.

for privacy