Lokkevik, E., Skovlund, E., Reitan, J.B., Hannisdal, E., & Tanum, G. (1996). Skin treatment with Bepanthen cream versus no cream during radiotherapy. Acta Oncologica, 35, 1021–1026.

To compare Bepanthen cream with no topical ointment

Patients used Bepanthen on one side of the treatment field and used no topical treatment on the other side. Patients were instructed to not inform the physician of which region or field received the application of the cream, and they randomized their own application. Bepanthen twice a day began on day 1 of radiation therapy. Skin assessments were performed weekly during treatment and two weeks following treatment.
 

• The study sample (N = 79) was comprised of patients with breast (n = 63) and T1 and T2 N0, M0 laryngeal (n = 16) cancer.
• Median age of patients with breast cancer was 55 years, with a range of 31–78 years. Median age of patients with laryngeal cancer was 69 years, with a range of 51–85 years.
• Patients with laryngeal cancer received definitive radiation therapy at 2 Gy/fraction and total dose of 70 Gy.
• Twenty-one patients with breast cancer received low-dose cyclophosphamide, methotrexate, and 5-fluorouracil during radiation therapy at cobalt-60 and total dose of 50 Gy.

The study used a quasi-experimental blinded trial design.

• The European Oncology Radiation Therapy Consortium and Radiation Therapy Oncology Group acute skin reaction scoring was recorded weekly, two, and six to eight weeks following treatment.
• Erythema was chosen as the primary efficacy variable.
• Wilcoxan-Signed Rank-Test was used for the primary and secondary efficacy variables.
• Logistic regression analysis was performed to examine the effect of concomitant chemotherapy, skin type, gender, age, and upper verses lower area (for patients with breast cancer only).

For both cancers, all skin reactions were more severe at completion of six weeks of radiation treatments, which was chosen as a reference point to standardize assessment data. No significant difference was observed in erythema, most desquamation, itch, or pain. No significant effect of any of the variables was found in regression analysis regarding erythema and desquamation.
 

Bepanthen did not provide any significant benefit.

• In patients with breast cancer, there were many different techniques of radiation therapy administration and use of bolus.
• No information about patient adherence to the protocol was provided.
• The two groups of cancers treated received different accumulative doses of irradiation.
• Data was not separated for those who also received chemotherapy, which would affect skin toxicity.

Tissue toxicity is associated with 60-cobalt.