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Study summary · research use only

Thêta-Cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care?

RCT · human · Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2004 · DOI 10.1007/s00066-004-1174-9 · PMID 15127162

Plain-language summary

Paraphrased from the published abstract below — not a verdict on whether anything works.

In this prospective randomized study, 20 breast cancer patients undergoing post-surgical radiotherapy were assigned to skin care with Theta-Cream (containing CM Glucan, Hydroxyprolisilan C, and Matrixyl) or standard Bepanthol lotion, with acute skin toxicity scored at 0, 30, and 50 Gy using a modified RTOG system. The authors report no differences in median toxicity between groups; maximal toxicity averaged moderate erythema, mild skin-temperature elevation, and no desquamation in both. Mild itchiness and sporadic efflorescences were more frequent with Theta-Cream, and adverse events (a suspected allergic reaction, two resimulations) occurred only in Theta-Cream users. Patient satisfaction was high with both. The authors report no advantage for Theta-Cream and note higher costs and skin-mark problems.

Abstract

In radiotherapy of the breast following breast-conserving surgery, the adverse reaction predominantly found is confined to the skin. After phase II studies, Thêta-Cream, containing CM Glucan, Hydroxyprolisilan C und Matrixyl as active substances, was said to have prophylactic properties of preventing acute radiation side effects in skin tissue. In a prospective randomized study, Thêta-cream was compared with standard skin care using Bepanthol lotion. 20 breast cancer patients were randomly assigned to use Thêta-Cream or Bepanthol lotion during radiotherapy. At 0, 30, and 50 Gy, acute skin toxicity was scored with a modified RTOG scoring system. The patients' content with the skin care and the technical assistants' content with the skin marks were recorded. For single aspects of toxicity and their sums in defined skin areas, no differences in median and range between study groups were found. The maximal toxicity anywhere in the breast averaged in a moderate erythema, mild elevation of skin temperature, no desquamation in both groups. Mild itchiness and sporadic efflorescences were more frequently seen with Thêta-Cream. According to a ranking of anonymized breast photos at 50 Gy by independent investigators, side effects were equal. Patients' content was high with both skin care regimens (1.25 on a scale from 0 to 10). With Thêta-Cream a trend toward worse skin marks was noted. Adverse events exclusively occurred in Thêta-Cream users: suspected allergic reaction once, and the necessity for resimulation twice. In direct comparison with dexpanthenol-containing lotion, no advantage for Thêta-Cream was found. Higher costs and problems with skin marks prevent a general recommendation.

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