Röper, B., Kaisig, D., Auer, F., Mergen, E., & Molls, M. (2004). Thêta-cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care? Strahlentherapie und Onkologie, 180, 315–322.

Thêta-cream was compared with standard skin care using Bepanthol (Bepanthen) lotion to prevent acute radiation therapy (RT) side effects in skin tissue.

Patients were randomly assigned to use Thêta-Cream (GM Glucan, Hydroxyprolisilan C, Matrixyl) (arm A) or Bepanthol lotion (dexpanthenol) (arm B) during RT. Medication was applied lightly to the treatment field twice daily starting within one week before beginning RT. Patients were requested to wash irradiated skin gently with care to skin marks. No other prophylactic topical treatment was allowed.

• The sample was comprised of 20 women with early stage breast cancer. 
• Mean age was 56 years (range 43–65) for patients receiving Thêta-cream and 52 years (range 38–61) for patients receiving Bepanthol lotion.
• Treatment was given in a supine position with 6 mv photons of a linear accelerator with tangential.

The study was a randomized, blinded, controlled trial.

• All patients had thermo-luminescent dosimeter (TLD) measurements of the actual dose delivered to their skin surface once during their RT series.
• At 0, 30, and 50 Gy, acute skin toxicity was scored with a modified Radiation Therapy Oncology Group (RTOG) scoring system, by a single investigator.
• RTOG scoring was modified to allow for further discrimination of low scores.
• Five aspects of skin toxicity were scored separately with 0 to 3 points.
• 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 of each aspect of skin toxicity anywhere in the treatment fields was recorded, and median values were compared between the two groups. Total scores across all areas were calculated as well.
• Patients were asked if they would recommend it for other patients using a visual analog scale.
• The opinion of technical assistants in RT about skin marks was evaluated with a visual analog scale.

• At 50 Gy, there was an insignificant trend in favor of Bepanthol lotion.
• There was no difference for maximal scores in every single aspect of skin toxicity for both groups at 30 Gy.
• No difference was found in patient preference.

In direct comparison with dexpanthenol-containing lotion, no advantage for Thêta-Cream was found.

• The study had a small sample size.
• Patients in the Thêta-Cream group were slightly older and more often had ongoing hormonal treatment.
• Validity and reliability of the modified RTOG scoring system was not discussed.
• The article states random assignment, but the study plan states patients were alternately assigned into two groups without further stratification.