Roper, B., Kaisig, D., Auer, F., Mergen, E., & Molls, M. (2004). Theta-cream versus bepanthol lotion in breast cancer patients under radiotherapy. Strahlentherapie und Oncologie, 180, 315–322.

To compare Theta-cream with standard skin care using Bepanthol (Bepanthen) lotion to prevent acute radiation side effects in skin tissue

Patients were randomly assigned to use Theta-Cream or Bepanthol lotion during radiation therapy. Medication was applied lightly to the treatment field twice daily, starting within one week before beginning radiation therapy. Patients requested to wash irradiated skin gently with care to skin marks. No other prophylactic topical treatment was allowed.

• The study sample (N = 20) was comprised of female patients with early-stage breast cancer.
• Mean age was 56 years for the Theta-Cream group and 52 years for the Bepanthol lotion group, with a range of 43–65 and 38–61 years, respectively. 

The study used a randomized controlled blinded trial design.

• All patients had thermoluminescent dosimeter (TLD) measurements of actual dose delivered to skin surface once during their radiation series.
• At 0, 30, and 50 Gy, acute skin toxicity was scored with modified Radiation Therapy Oncology Group (RTOG) scoring; RTOG scoring was modified for further discrimination of low scores.
• Erythema, desquamation, and efflorescence were judged by inspection; elevation of skin temperature in comparison with the contralateral breast by palpation; and itchiness according to patients’ statements.
• Skin toxicity was scored separately for three localizations. The maximal score was recorded and median values were compared between the two groups.
• Patients were asked for subjective content with their skincare regimen and if they would recommend it for other patients using a visual analog scale.

At 50 Gy, there was a insignificant trend in favor of Bepanthol lotion with a median total score of 8 (range 3–14) versus 11 (range 3–15) with Theta-Cream. There was no difference for maximal scores in every single aspect of skin toxicity for both groups at 30 Gy.

In direct comparison with dexpanthenol-containing lotion, no advantage for Theta-Cream was found. There were no differences in skin toxicity between groups using Theta-Cream or Bepanthen.

• The study had a small sample size, with less than 50 patients.
• Patients in the Theta-Cream group were slightly older and more often had ongoing hormonal treatment.
• Validity and reliability of modified RTOG scoring system was not discussed.
• Article states random assignment, but study plan states patients were alternately assigned into two groups.