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

determining the effect of Plantago major leaf gel compared to placebo on prevention of acute radiation dermatitis in breast cancer patients

Randomized clinical trial with control group ,double blind, phase 2, on 80 patients. Random allocation software 2.0 uses for randomization.

The study site is Shiraz Namazi hospital which is the center for cancer patients radiotherapy. The study is double blind. The patients and researchers are blinded.The duration of treatment is 7 weeks. Patients Will be followed up for the duration of radiation and 2 weeks after the last radiation therapy session and visited weekly.

inclusion criteria: breast cancer patients who need external radiotherapy 18 years old and more exclusion criteria: previous chest radiotherapy skin tumor rash,ulcer,scar connective tissue disease diabetes mellitus concomitant chemotherapy

Eighty patients are selected from the target population and randomly divided into two equal groups. Patients will be use plantago major gel in intervention group and placebo in control group. Patients in both groups will be instructed to cover the area under radiation with a thin layer of topical gel twice a day (morning and night). Treatment in both groups will continue from the first day of radiation therapy to two weeks after the last radiation therapy session.

Dermatitis grade

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.

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.

for privacy