Evaluating the evaluation of calendula oil nanoemulsion containing hydrocortisone in management of dermatitis following radiotherapy in breast cancer: a randomized double blind clinical trial

Evaluating the evaluation of calendula oil nanoemulsion containing hydrocortisone in management of dermatitis following radiotherapy in breast cancer

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 51 patients. Randomization using rand function of Excel software

Radiotherapy is performed with a dose of 2 Gy to 50 Gy to all breast tissue (boost dose of 10 to 14 Gy). The desired gel is applied twice a day on the skin of the irradiated area, the first time with a short time from receiving the radiation. At the time of radiation, the skin must be completely clean. The examination is done once a week and continues for at least 2 weeks after the end of the treatment. Blinding: All three formulations will be placed in identical packages. The randomized code will be written on the medicine package.

Patients with breast cancer who have been referred to the radiotherapy department of Imam Ali Bojnoord Hospital for radiotherapy. Non-entry criteria: Complete mastectomy Background or active skin disease Breast wound that has not been repaired Allergy to hydrocortisone or calandola essential oil Exit criteria: Patient's decision to discontinue cooperation at any stage of the study Occurrence of unexpected side effects Observation of grade 4 due to complications of radiation therapy during treatment

Study groups: Gel containing marigold oil nanoemulsion containing 1% hydrocortisone Gel containing marigold oil nanoemulsion (without medicine) empty gel

Reduction of skin side effects of radiotherapy

Eligible patients are randomly divided into three groups using permuted block randomization (1:1:1) with a block size of three: the first two intervention groups are gel containing calendula oil nanoemulsion containing 1% hydrocortisone and the second intervention group is gel. containing calendula oil nanoemulsion (without drug) and a blank gel placebo group. The order of the blocks is also random. Due to the study's modified blocked randomization design, the entire randomization list will be generated before a patient is enrolled. Then the prepared list is numbered from the beginning of the list. Allocation of numbers to the studied groups is confidential and not disclosed to the research team. Therefore, with this numbering, the research team involved in the intervention process is blinded to the assigned treatment. These numbers are also included in the medicine and placebo package. After randomization into the trial, patients receive the next sequence based on the randomization list.

All three formulations will be placed in similar packages. The randomized code will be written on the medicine package. Of course, due to the difference in smell, we try to conduct individual interviews for patients so that patients are not able to compare the drugs. The secretary or colleague of the plan is asked to deliver the medicine to the patients according to the random number stamped on the sheet in the patient's prescription. The researcher will not know about what disease and what medicine he took. Also, the attending physician will not be aware of the patient's medication. The patient is asked to hand over the container of the used medicine to the project partner in the next visit and collect the same number from the pharmacy in the next visit. The information for statistical analysis will be provided to them in a blinded form.

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