Rizza, L., D'Agostino, A., Girlando, A., & Puglia, C. (2010). Evaluation of the effect of topical agents on radiation-induced skin disease by reflectance spectrophotometry. The Journal of Pharmacy and Pharmacology, 62(6), 779–785.

To evaluate the effects of two topical agents (Biafin and an emulsion made of natural extracts containing Capparis spinosa, Opuntia coccinellifera, and olive leaf extracts) used supportively to minimize radiation-induced erythema and skin reactions using noninvasive instrumental methods  

Patients applied a thin layer of one of the two topical agents twice daily starting the first day of radiotherapy. The topical formulations were not applied within four hours of the radiation session. Skin regions in the radiation field that were assessed were divided into three areas: lateral breast, medial breast, and area under the breast. For each skin region, skin reaction was evaluated by an instrumental erythema index obtained from non-invasive reflectance spectrophotometry and recorded once per week. Visual assessment regarding erythema, edema, desquamation and ulceration of each region was performed in weekly inspections using the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) scoring system. Photo documentation of treated skin was done to verify the RTOG/EORTC visual score.

• The study sample (N = 68) was comprised of female patients with breast cancer.   
• Mean age of the sample was 50 years, with a range of 38–65 years.
• Patients were undergoing radiation therapy after breast-conserving surgery.
• Patients were excluded from the study if they showed signs of cutaneous disease (rash, bleeding, ulceration or unhealed scar) or had an allergy or sensitivity to the formulations.
   

The study took place at the Department of Radiotherapy at Humanitas Centro Catanese di Oncologia in Italy.

Patients were undergoing active treatment for cancer. The study has clinical applicability for late effects and survivorship.

The study used a double-blinded, computer-generated, randomized design with nontreatment control groups monitored over eight weeks.

• Weekly reflectance spectrophotometry-noninvasive instrumental method was used, with skin reactions measured via light reflectance instrument, and erythema index measured.  
• Weekly RTOG/EORTC visual score was used to grade acute toxicity of radiation-induced skin erythema.
   

The 68 patients were randomized as follows: 26 subjects randomly received treatment A (the topical emulsion made of herbal extracts), 24 patients received treatment B (Biafin), and 18 subjects received no treatment. A significant increase in erythema index was seen in the nontreatment group after the second week of radiation, with maximal values recorded between weeks 4 and 6 of treatment. Formulation A was significantly more effective than B in preventing or reducing radiotherapy-induced skin reactions (p < 0.05). The modified RTOG/EOTRC visual score system showed that both treatment A and treatment B were effective against the development of erythema in comparison with the nontreatment group (p < 0.01). There was no significant difference in the RTOG/EOTRC visual score system between treatment A and treatment B in reducing skin erythema induced by radiation therapy.

Use of topical emollients at the onset of radiation therapy and throughout treatment twice per day is effective at reducing the appearance of skin erythema for patients with breast cancer undergoing radiation therapy. Patients not using topical emollients at all during radiation treatment results in increased erythema and desquamation in irradiated skin areas. The use of reflectance spectrophotometry showed that early erythema could be reduced with the application of topical emollients.

• The sample size was small, with less than 100 participants.
• The study was done in Italy. It is not clear that U.S. institutions routinely use reflectance spectrophotometry to measure skin reactions from radiation therapy. The feasibility of using this method is not known.
• The article doses not describe who was performing either the visual assessments or the reflectance spectrophotometry. The training of personnel or staff used for these assessments is not known.  
• The study took place at a single site.
• It is unclear if the herbal extract blend is reproducible.
   

The use of topical agents applied to radiated skin fields at least twice per day throughout treatment is more effective than no treatment at all to reduce the incidence of skin reactions and early erythema. The research study article supports the use of topical agents containing ingredients that can provide protective effects against skin damage incurred during radiation therapy. The reduction of skin irritation with the use of Biafin or herbal extracts supports recommendation of the routine use of topical emollients for all patients receiving radiotherapy who have the potential for skin reactions with treatment.