title: Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.
abstract: OBJECTIVE
  To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of ≥ Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care.
  
  
  METHODS
  Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid-based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of ≥ Grade 2 dermatitis.
  
  
  RESULTS
  The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of ≥ Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only one patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003).
  
  
  CONCLUSIONS
  We found no benefit from the use of a topical hyaluronic acid-based gel for reducing the development of ≥ Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid-based gel in controlling radiation dermatitis symptoms after they develop.
authors.affiliation: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Chelsea
authors.initials: C
authors.lastname: Pinnix
authors.forename: George H
authors.initials: GH
authors.lastname: Perkins
authors.forename: Eric A
authors.initials: EA
authors.lastname: Strom
authors.forename: Welela
authors.initials: W
authors.lastname: Tereffe
authors.forename: Wendy
authors.initials: W
authors.lastname: Woodward
authors.forename: Julia L
authors.initials: JL
authors.lastname: Oh
authors.forename: Lisa
authors.initials: L
authors.lastname: Arriaga
authors.forename: Mark F
authors.initials: MF
authors.lastname: Munsell
authors.forename: Patrick
authors.initials: P
authors.lastname: Kelly
authors.forename: Karen E
authors.initials: KE
authors.lastname: Hoffman
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Smith
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Buchholz
authors.forename: T Kuan
authors.initials: TK
authors.lastname: Yu
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D001940:Breast / Q000033:anatomy & histology; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D057239:Early Termination of Clinical Trials; D004643:Emollients / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009929:Organ Size; D010577:Petrolatum / Q000008:administration & dosage*; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D011855:Radiodermatitis / Q000473:pathology / Q000517:prevention & control*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016037:Single-Blind Method; D017211:Treatment Failure
chemical_list: D004643:Emollients; D011837:Radiation-Protective Agents; D010577:Petrolatum; D006820:Hyaluronic Acid