The effect of topical use of Chicory root extract gel on the incidence and severity of radiation therapy-induced dermatitis in breast cancer patients.

Determining the effect of topical use of chicory root extract gel on the incidence and severity of radiation therapy-induced dermatitis in breast cancer patients

Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 44 patients. (Sealed Envelope software, London, UK) was used for randomization.

This study will be performed in the radiotherapy ward of yasrebi Hospital in Kashan-Iran. Patients with random entry criteria will receive chicory gel and placebo. The gel will be used twice a day from the beginning of radiation therapy until the end of the radiation therapy period (one month) in the position under radiation therapy. Patients, researchers, statistical analysts and treatment team will not be aware of the patient group.

Willingness to participate in the study, giving informed consent؛ Breast cancer based on the diagnosis of an oncologist؛ Lack of known allergy to chicory plant and medical contraindication to chicory extract؛ Absence of ulcers or unhealed scars at the site of radiation therapy؛ No history of radiation therapy at the current treatment site؛ No history of breast reconstruction (prosthesis) and concomitant chemotherapy

Patients will not be deprived of any routine care and treatment by participating in the study. Both intervention and placebo groups will use gel-containing tubes topically twice a day, from the first day of radiation therapy to one month (until the end of radiation therapy). Gel tubes are coded for blinding. Patients in the intervention group will use 3% chicory root gel extract tube and placebo group will use placebo gel tube which is without active ingredient. Gel tubes are matched in appearance.

Incidence of radiation-induced dermatitis؛ Severity of radiation-induced dermatitis

Patients who meet the inclusion criteria are consecutively entered into the study and coded, then they are randomly divided into 11 blocks of 4 using a (Sealed Envelope software program, London, UK) . In each block, two people will be randomly assigned to the intervention group and two people to the placebo group. The randomization process is done by the first researcher. The second researcher, who is involved in the daily sampling and evaluation of patients, is blinded to the placement of the individual in the intervention or placebo group.

The first executor uses a software program (Sealed Envelope software, London, UK) to randomly place people based on 4 blocks in two intervention groups (22 people) and placebo (22 people) and a list of codes Creates a dedicated and randomly assigns each patient to the intervention group and placebo. The first performer of the study, according to the code assigned to the patient, delivers 100 g tubes containing chicory root extract or placebo gel, which is encoded, to the second performer to provide to the patients. The second executor has been blinded to the allocation of individuals in study groups and drug tubes. Due to the coding of the evaluator, the treatment team and the patient are blinded to being in the desired group. Also, the statistical analyzer will perform the analysis according to the codes without knowing the groups.