Abstract

PURPOSE
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 AND MATERIALS
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).
CONCLUSION
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.

Links

Publisher Full Text

Authors

Pinnix C, Perkins GH, Strom EA, Tereffe W, Woodward W, Oh JL, Arriaga L, Munsell MF, Kelly P, Hoffman KE, Smith BD, Buchholz TA, Yu TK

Institution

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.

Source

International journal of radiation oncology, biology, physics 83:4 2012 Jul 15 pg 1089-94

MeSH

Administration, Topical
Adult
Aged
Breast
Breast Neoplasms
Early Termination of Clinical Trials
Emollients
Female
Humans
Hyaluronic Acid
Mastectomy, Segmental
Middle Aged
Organ Size
Petrolatum
Radiation-Protective Agents
Radiodermatitis
Radiotherapy, Adjuvant
Single-Blind Method
Treatment Failure

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22172912