Topical use of chicory root extract gel on the incidence and severity of radiodermatitis in breast cancer patients: a randomized controled trial.

Abstract

Background and purpose: Nearly 95% of women treated with radiotherapy for breast cancer experience some degree of radiodermatitis. Radiation therapy's most frequent side effect is skin damage. Managing radiation-induced skin reactions while maintaining treatment continuity is a challenging issue. The chicory plant has known anti-inflammatory properties. This study aimed to assess the effect of chicory root extract gel on the incidence and severity of radiodermatitis in breast cancer patients.

Materials and methods: This three-blind clinical trial was conducted in the radiation therapy department of Ayatollah Yasrebi Hospital in Kashan from September 2022 to February 2023. Forty-four breast cancer patients undergoing radiation therapy with a linear accelerator were randomly assigned to either the intervention group (n = 21) or the placebo group (n = 20). Participants applied topically chicory root extract gel or placebo twice daily, starting with their radiation therapy. The incidence and severity of dermatitis were assessed using the Radiation Therapy Oncology Group (RTOG) scale. Participants' characteristics were collected through a researcher-designed questionnaire. Data analysis was performed using chi-square tests, Fisher's exact test, independent t-tests, Mann-Whitney U tests, and generalized linear models with a Poisson distribution, using SPSS version 16 software.

Results: No significant differences were found between the two groups regarding individual and clinical characteristics at the beginning of the study. The results indicated that the number of patients who did not develop dermatitis in later weeks was higher in the intervention group compared to the placebo group (P < 0.001). In the second and third weeks, grade 1 and 2 dermatitis incidence was higher in the placebo group than in the intervention group (P < 0.001). A comparison of the incidence of dermatitis between the two groups, in terms of the number of days to develop grade 1 dermatitis, showed that the average duration was longer in the intervention group than in the placebo group (P > 0.05). This comparison was insignificant for grade 3 dermatitis in either group. Additionally, when considering body mass index (BMI) as a confounding variable and adjusting for its effect, the results revealed that the intervention group developed grade 1 dermatitis significantly later than the placebo group (P < 0.001).

Discussion and conclusion: Chicory root extract gel offers an effective, low-risk option for managing radiodermatitis in breast cancer patients. This aligns with the goals of supportive cancer care, which emphasize minimizing side effects, maintaining treatment efficacy, and improving the patient's quality of life.

Trial registration: The study was registered in the Clinical Trials Center of Iran ( https://irct.behdasht.gov.ir ) with the number cod: IRCT20220601055055N1 on July 2, 2023.