title: Can we decrease the skin reaction in breast cancer patients using hyaluronic acid during radiation therapy? Results of phase III randomised trial.
abstract: OBJECTIVE
  Radio-induced early skin reactions still remain a clinical challenge. Preliminary results with Hyaluronic acid, one of the most recent topical products used in this indication are proving interesting. To evaluate the efficacy of Hyaluronic acid compared to placebo.
  
  
  METHODS
  Breast cancer patients with grade 1-2 radio-induced dermatitis during postoperative radiotherapy were eligible. They were randomised to receive either hyaluronic acid (A) or a simple emollient (B). The primary endpoint was the clinical evaluation of the erythema (success versus failure). Secondary endpoints were the evaluation of skin colorimetry, pain, and quality of life.
  
  
  RESULTS
  Two-hundred patients were enrolled (A=99, B=101). Ninety-five patients per treatment arm could be evaluated. Failures occurred in 23 patients (24%) in the hyaluronic acid arm, and 32 (34%) in the emollient arm (p=0.15). Seventy-three patients (36.5%) prematurely stopped the treatment without any ensuing difference between the two arms. Body mass index and the size of the epithelitis were both independently associated with the failure of the local treatment. The relative reduction of colorimetric levels was 20% in the hyaluronic acid group, and 13% in the emollient group (p=0.46). Concerning the quality of life assessment, there was a trend towards a lower level of pain in patients receiving hyaluronic acid (p=0.053).
  
  
  CONCLUSIONS
  The present study showed no significant difference between hyaluronic acid and simple emollient in the treatment of acute radio-induced dermatitis. There was however a trend towards an improvement in both pain level and skin colorimetry.
authors.affiliation: Department of Radiation Oncology, Institut Curie, Paris, France. youlia.kirova@curie.net
authors.forename: Youlia M
authors.initials: YM
authors.lastname: Kirova
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fromantin
authors.forename: Yann
authors.initials: Y
authors.lastname: De Rycke
authors.forename: Alain
authors.initials: A
authors.lastname: Fourquet
authors.forename: Esra
authors.initials: E
authors.lastname: Morvan
authors.forename: Solene
authors.initials: S
authors.lastname: Padiglione
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Falcou
authors.forename: Francois
authors.initials: F
authors.lastname: Campana
authors.forename: Marc A
authors.initials: MA
authors.lastname: Bollet
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000532:radiotherapy*; D003872:Dermatitis / Q000188:drug therapy*; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008875:Middle Aged; D011832:Radiation Injuries / Q000188:drug therapy*; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D004643:Emollients; D006820:Hyaluronic Acid