Related Pages Search for Clinical Trials NCI's PDQ® Cancer Clinical Trials Registry. Breast Cancer Home Page NCI's gateway for information about breast cancer.

Key Words

Breast cancer, calendula ointment, dermatitis, radiation therapy, trolamine ointment. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

In a French study, women with breast cancer who received radiation therapy after surgery suffered less skin irritation if they applied calendula ointment to the irradiated area than if they used another ointment, trolamine. As of May 2004, the particular calendula ointment used in the study was not available in the United States.

Source

Journal of Clinical Oncology, April 15, 2004.

Background

Many women with breast cancer receive radiation therapy following surgery either to remove the affected breast (mastectomy) or conserve the breast while removing the tumor (lumpectomy). Dermatitis, a condition that causes the skin in the breast area to become red, itchy, and blistered, is a common, sometimes painful side effect of radiation therapy that may lead some women to temporarily stop treatment.

A variety of creams and ointments may be prescribed to prevent or treat dermatitis caused by radiation therapy. Trolamine ointment is widely used, although randomized studies have not shown it to be more effective than other approaches to preventing and treating radiation-induced dermatitis.

The Study

This phase III study compared the effectiveness of calendula ointment with that of trolamine in preventing moderate to severe dermatitis caused by radiation therapy for breast cancer. A total of 254 patients at a regional cancer center in France were randomly assigned to apply one ointment or the other to their irradiated skin at least twice a day for the duration of their radiation treatment. The application of the product began on day one of radiation and continued throughout treatment, in contrast to the usual approach in the United States, where application begins only when dermatitis is first noted.

The study was single-blinded, meaning that patients – but not their doctors – knew which ointment they were using. Differences in the texture, color, and smell of the two ointments meant that patients could not be kept in the dark about which product they were using. To keep this information from their doctors, however, patients were instructed not to apply the ointment within two hours or less of seeing their doctor.

Patients were not permitted to use other creams, ointments, or gels on their irradiated skin. Skin irritation and pain were assessed at weekly doctor visits. At the end of the study, patients were asked how satisfied they were with the relief of dermatitis and pain and with the ease of applying the ointment. The study’s principal investigator was Xavier Montbarbon, M.D., of the Centre Leon Berard in Lyon, France.

Results

Moderate to severe dermatitis occurred in 41 percent of patients treated with the calendula ointment, compared with 63 percent of those treated with trolamine. Patients who used calendula reported less severe pain than those who used trolamine.

Thirty percent of patients using calendula found the ointment difficult to apply, compared with only five percent of those using trolamine. However, patients using calendula were significantly more satisfied with the relief of dermatitis and pain than those who used trolamine.

Women in both groups were at higher risk for moderate to severe dermatitis if they had a body mass index of 25 or higher or if they had had a lumpectomy followed by chemotherapy before undergoing radiation.

Limitations

The number of patients enrolled in this study was small for a phase III trial, says Paul Wallner, D.O., chief of the National Cancer Institute’s Clinical Radiation Oncology Branch. In addition, the trolamine group may have contained an excessive number of women at high risk for dermatitis, which could have made trolamine appear less effective.

Comments

The calendula ointment tested in this study might be helpful for women who are at higher risk for radiation-induced dermatitis, adds Wallner. This particular ointment is not currently available in the United States, however, and Wallner cautions that those calendula-based skin products that are available may not contain the same amount or mixture of ingredients, and so may not be as effective.

Back to Top