Sharp, L., Finnilä, K., Johansson, H., Abrahamsson, M., Hatschek, T., & Bergenmar, M. (2013). No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions – Results from a randomised blinded trial. European Journal of Oncology Nursing, 17, 429–435. 

To compare two topical agents (Calendula Weleda^® cream and Essex^® cream) in reducing the risk of severe acute radiation skin reactions in women receiving adjuvant radiation therapy for breast cancer

Patients randomly were assigned one of two creams (Calendula or Essex) and applied a thin layer twice daily from the beginning of radiotherapy through two weeks after their final radiation treatment or until the skin reaction healed. The cream was not applied within two hours of the radiation treatment. Patients were advised to wash daily with nonperfumed soap and told not to apply other topicals in the radiation field. Patients completed questionnaires related to quality of life (European Organization for Research and Treatment of Cancer [EORTC]-QLQ C30), sleep (MOS), and symptoms (e.g., pain, tenderness, burning, pulling, itching) related to the radiation field on a visual analog scale.

• N = 411    
• MEAN AGE = 58 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with breast cancer who had previous partial or modified radical mastectomy and were to undergo adjuvant external beam radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Treatment fractions were 2Gy per day, five days per week, up to 50Gy total dose, or 2.66Gy per day, five days per week, up to a total dose of 42.56Gy. All patients younger than 40 years had a boost of 16Gy in 2Gy per fraction. Treatment was photons 6MV or in combination with 15MV or 18MV.

• SITE: Single institution  
• SETTING TYPE: Radiation unit  
• LOCATION: Department of Oncology at Karolinska University Hospital

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Adults 

• Two arm, blinded, randomized phase III trial

• Primary endpoint statistics: Fisher’s exact test
• Secondary endpoint: Linear regression
• The primary endpoint of this study was the difference in the proportion of patients with severe acute radiation skin reactions using the Radiation Therapy Oncology Group (RTOG)/EORTC scale for radiation morbidity scoring criteria.
• Patients were evaluated by radiation therapy nurses who had received education on the use of the RTOG/EORTC scale in the form of 90-minute workshops and lectures.
• Assessment took place on three occasions: the first day of radiation treatment, the last day of treatment, and at a follow-up visit 5–17 days after the final radiation treatment.
• The secondary endpoint of this study was patient-reported outcomes (using quality of life and sleep questionnaires and symptom ratings on a visual analog scale).

Researchers found no statistically significant difference in severe acute radiation skin reactions in the group using Calendula cream versus the group using Essex cream (a water-based topical emollient, which is the standard of care in that institution.) Severe acute radiation skin reaction (RTOG/EORTC grade less than or equal to 2) was 23% in the Calendula group versus 19% in the Essex group. There were no differences in patient-reported outcomes in terms of pain, burning, itching, pulling, or tenderness at the radiation site. However, there was a statistically significant difference in patient evaluation of application and absorption of the cream in favor of Essex cream.

There was no difference in severe acute radiation skin reactions in women with breast cancer using Calendula cream or Essex cream during radiation therapy.

• Key sample group differences that could influence results
• Other limitations/explanation: The timing of the follow-up visit was variable at a length of 5–17 days post-radiation therapy. Treated skin heals over time, and a more acute skin reaction is likely at five days post-treatment versus two weeks or longer off treatment.

Patients with breast cancer undergoing curative radiation therapy may experience a less severe acute radiation skin reaction using twice daily application of Calendula cream or an aqueous-based cream. Future studies could include patients with other types of cancer and different treatment fields to compare benefits of these topical emollients.