Calendula ointment and radiation dermatitis during breast cancer treatment

Townsend Letter for Doctors and Patients, April, 2005 by Tori Hudson

Pommier P, Gomez F, Sunyach M, et al. J of Clinical Oncology 2004;22(8):1447-1453

The aim of this study was to compare the effectiveness of calendula ointment (Boiron Ltd.) with that of trolamine, a topical nonsteroidal agent for the prevention of radiation-induced dermatitis in breast cancer. Trolamine is an oil-in-water emulsion that can enhance the healing of the skin by modifying immunomodulators and recruiting macrophages. The secondary objectives were to assess pain, radiation treatment interruption as a result of skin reactions, patient satisfaction, and the quantity used.

Two-hundred fifty-four women were seen who had been operated on for breast cancer and were to receive postoperative radiation therapy. Half were assigned to the trolamine group and half to the calendula group. They applied the agents to the irradiated fields after each session, twice daily or more, depending on the occurrence of dermatitis and pain, until the completion of their radiotherapy. The incidence of acute skin toxicity of grade 2 to 3 was 41% (95% CI, 37 to 46) in the group given calendula and 63% (95% CI, 59 to 68) in the trolamine group. Nine patients given calendula and 20 patients given trolamine presented with a grade 3 toxicity. There were no patients who had a grade 4 toxicity. The benefits were the most significant at the submammary fold, armpit and tangential area, and sites that had thin skin. Radiation treatment interruption occurred with only one patient receiving calendula (unrelated to skin toxicity) and for 15 patients receiving trolamine; (12 because of skin toxicity, 1 because of a lymphocele abscess and 2 unrelated to radiotherapy.)

Calendula ointment was statistically significantly superior to trolamine for the prevention of skin toxicity of grade 2 or higher, and for other end points including allergy, interruption of treatment, patient satisfaction, pain relief and dermatitis. Patients were also able to use a lesser quantity of calendula than trolamine. The only inferior aspect of calendula according to patients was that it was considered to be more difficult to apply than the trolamine.

Commentary: About 200,000 women a year in the US are newly diagnosed with breast cancer. A large portion of these women will receive conservative surgery and radiotherapy. In approximately 80% of patients, irradiation will induce mild to severe dermatitis. Consequences include pain, skin damage, and interruption of treatment. Various nonsteroidal creams, corticosteroid creams, herbal creams, vitamin E ointment, and aloe vera creams are commonly used to prevent radiation dermatitis. Two small studies have shown that corticosteroid cream was more effective than an emollient cream and only a few randomized trials have shown the noncorticosteroid creams are superior to placebo. No large randomized studies have demonstrated the efficacy of a topical nonsteroidal cream in the prevention of radiation-induced dermatitis in breast cancer patients.

In a previous randomized, open, parallel study, calendula was shown to be effective for the local treatment of second and third degree burns. It has been used historically for contact and atopic dermatitis, nonspecific skin lesions, and superficial burns.

I am pleased to learn of this study, showing the effectiveness and even superiority of calendula ointment in preventing acute dermatitis during postoperative breast irradiation. The clinical relevance may easily extend to other patients receiving external beam radiotherapy.

This specific calendula ointment product is not yet available in the US.