Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer.
OBJECTIVE
The effectiveness of nonsteroid topical agents for the prevention of acute dermatitis during adjuvant radiotherapy for breast carcinoma has not been demonstrated. The goal of this study was to compare the effectiveness of calendula (Pommade au Calendula par Digestion; Boiron Ltd, Levallois-Perret, France) with that of trolamine (Biafine; Genmedix Ltd, France), which is considered in many institutions to be the reference topical agent.


METHODS
Between July 1999 and June 2001, 254 patients who had been operated on for breast cancer and who were to receive postoperative radiation therapy were randomly allocated to application of either trolamine (128 patients) or calendula (126 patients) on the irradiated fields after each session. The primary end point was the occurrence of acute dermatitis of grade 2 or higher. Prognostic factors, including treatment modalities and patient characteristics, were also investigated. Secondary end points were the occurrence of pain, the quantity of topical agent used, and patient satisfaction.


RESULTS
The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% v 63%; P <.001) with the use of calendula than with trolamine. Moreover, patients receiving calendula had less frequent interruption of radiotherapy and significantly reduced radiation-induced pain. Calendula was considered to be more difficult to apply, but self-assessed satisfaction was greater. Body mass index and adjuvant chemotherapy before radiotherapy after lumpectomy were significant prognostic factors for acute dermatitis.


CONCLUSIONS
Calendula is highly effective for the prevention of acute dermatitis of grade 2 or higher and should be proposed for patients undergoing postoperative irradiation for breast cancer.
Pommier
P
P
Department of Radiation Oncology, Centre Léon Bérard, 28 rue Laënnec, 69373 Lyon Cedex 08, France.
Gomez
F
F
Sunyach
M P
MP
D'Hombres
A
A
Carrie
C
C
Montbarbon
X
X
D000208:Acute Disease; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000532:radiotherapy*; D020838:Calendula; D003131:Combined Modality Therapy; D004983:Ethanolamines / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009824:Ointments / Q000627:therapeutic use; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D011832:Radiation Injuries; D011855:Radiodermatitis / Q000517:prevention & control*; D018714:Radiotherapy, Adjuvant
D004983:Ethanolamines; D009824:Ointments; D010936:Plant Extracts; C009546:triethanolamine