Written by Chrystal Moulton, Science Writer. By week 4, the incidence of skin lesions was significantly lower in the intervention group compared to the control (71.4% versus 91.4%, P = 0.031, respectively).
Those who undergo radiation therapy commonly experience radiation induced dermatitis. Roughly 95% develop moderate to severe reactions1. Initial treatment includes moisturizers, emollients neutral soaps, essentially non-pharmacological treatments. However, in more severe cases, drug treatment along with natural products are commonly used. Aloe Vera and chamomile, which are commonly found in natural products used to manage dermatitis, has contradicting evidence regarding the efficacy in treating dermatitis2-5. However, since there is no standard formulation and potency proven to ameliorate skin lesions as a result of radiation therapy, targeted clinical research is needed to determine a natural product that could substantially improve skin lesions specific to radiation induced dermatitis6. In the current trial, researchers investigated the effect of Alantel cream— a cream specifically formulated to treat dermatitis —on patients with breast cancer undergoing hypo-fractionated radiation therapy6.
This study was a prospective, multicenter, randomized, double-blind, controlled trial with two parallel groups. Eligible participants were women diagnosed with breast cancer requiring radiation therapy who were 18 years or older. Patients were excluded if: they had a history of connective tissue disorders, invasive skin cancer or lesions, severe mental disorder, sensitivity to the ingredients within the creams investigated, severe or extensive burns, drainage, moisture or erosion in the treatment area, or were involved in other clinical trials. Participants were randomly assigned to receive Alantel cream [intervention] or a regular moisturizing emollient containing beeswax [control]. At baseline (V0), researchers collected demographic and pathological information from each patient while also assessing the area of the skin undergoing radiation therapy. Participants were instructed to begin applying their assigned creams two days before the start of radiation therapy on the affected area. They were to apply it twice daily: two hours before radiation therapy in the morning and two hours after radiation therapy ended. Patients were instructed to do this before and after each session for three weeks [15 sessions]. At the 4th week, patients were instructed to apply their assigned creams twice daily. At each visit, clinicians performed an assessment of the patient’s skin undergoing radiation therapy, evaluated any dermal lesions, recorded any adverse events, collected data on the effect of the dermatitis from the patient’s point of view, and conducted the Skindex-29 questionnaire on the last visit during week 4 (assessing patient quality of life). Primary outcomes measured was the onset of radiation induced dermatitis as well as the duration. Researchers also assessed quality of life along with the size and severity of any dermal lesions that developed.
A total of 70 patients were randomly allocated to the intervention (n= 35) and control group (n= 35). The average age of patients was 55.29 ±11.44 years old with no statistical significance was seen between both groups. By week 4, researchers found the incidence of skin lesions was significantly lower in the intervention group compared to the control (71.4% versus 91.4%, P = 0.031, respectively). The relative risk of developing skin lesions in the intervention group compared to the control was 0.78 with an absolute risk reduction of 20% (P = 0.031). There was no significant differences between the number of skin lesions or toxicity in the intervention group versus the control from baseline to week 3. However, researchers did observe a larger number of skin lesions in patients treated with the control (97.1%) compared to those treated with the interventional cream (74.2%) at week 4. Furthermore, the mean duration of dermatitis in the intervention group was significantly lower than that of the control (8.96 ±4.28 days versus 10.94 ±6.28 days, P = 0.08). Ten adverse events were reported that were attributed to the creams with no significant differences found between the groups. However, no patients needed to withdraw from the trial as a result of these side effects. No significant differences were also observed between the groups in the quality-of-life questionnaires. Both experienced in decrease in quality of life as a result of radiation therapy.
Results from this trial demonstrate that Alantel cream could be a viable option for management of radiation induced dermatitis. Researchers highlighted that the cost of the Alantel cream was approximately $2.42 EUR higher than a standard moisturizing emollient cream; however, that the results from this trial demonstrated that the Alantel cream was more effective than a standard cream. Additional research will be needed to verify these results.
Source: Villegas-Becerril, E., C. Jimenez-Garcia, L. A. Perula-de Torres, M. Espinosa-Calvo, C. M. Bueno-Serrano, F. Romero-Ruperto, F. Gines-Santiago et al. “Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients (the Alantel study).” Contemporary Clinical Trials Communications 39 (2024): 101288.
© 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/bync-nd/4.0/).
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Posted June 11, 2024.
Chrystal Moulton BA, PMP, is a 2008 graduate of the University of Illinois at Chicago. She graduated with a bachelor’s in psychology with a focus on premedical studies and is a licensed project manager. She currently resides in Indianapolis, IN.
References:
- Rosenthal A, Israilevich R, Moy R. Management of acute radiation dermatitis: A review of the literature and proposal for treatment algorithm. J Am Acad Dermatol. Aug 2019;81(2):558-567. doi:10.1016/j.jaad.2019.02.047
- Heggie S, Bryant GP, Tripcony L, et al. A Phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nurs. Dec 2002;25(6):442-51. doi:10.1097/00002820-200212000-00007
- Williams MS, Burk M, Loprinzi CL, et al. Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity. Int J Radiat Oncol Biol Phys. Sep 1 1996;36(2):345-9. doi:10.1016/s0360-3016(96)00320-3
- Widjaja SS, Sumantri IB, Rusdiana R, et al. Potential Benefits of Aloe vera and Raphanus sativus var. longipinnatus Gel for Prevention of Radiation-Induced Dermatitis in Head and Neck Cancer Patients. Iran J Pharm Res. Dec 2022;21(1):e132213. doi:10.5812/ijpr-132213
- Tungkasamit T, Chakrabandhu S, Samakgarn V, et al. Reduction in severity of radiation-induced dermatitis in head and neck cancer patients treated with topical aloe vera gel: A randomized multicenter double-blind placebo-controlled trial. European journal of oncology nursing : the official journal of European Oncology Nursing Society. Aug 2022;59:102164. doi:10.1016/j.ejon.2022.102164
- Villegas-Becerril E, Jimenez-Garcia C, Perula-de Torres LA, et al. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients (the Alantel study). Contemp Clin Trials Commun. Jun 2024;39:101288. doi:10.1016/j.conctc.2024.101288