title: Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4.
abstract: OBJECTIVE
  A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy.
  
  
  METHODS
  Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy.
  
  
  RESULTS
  A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002).
  
  
  CONCLUSIONS
  Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.
authors.affiliation: Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA. miller.robert@mayo.edu
authors.forename: Robert C
authors.initials: RC
authors.lastname: Miller
authors.forename: David J
authors.initials: DJ
authors.lastname: Schwartz
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Griffin
authors.forename: Richard L
authors.initials: RL
authors.lastname: Deming
authors.forename: Jon C
authors.initials: JC
authors.lastname: Anders
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Stoffel
authors.forename: Robert E
authors.initials: RE
authors.lastname: Haselow
authors.forename: Paul L
authors.initials: PL
authors.lastname: Schaefer
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: James A
authors.initials: JA
authors.lastname: Martenson
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents; D001943:Breast Neoplasms / Q000532:radiotherapy*; D002278:Carcinoma in Situ / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000532:radiotherapy*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D011855:Radiodermatitis / Q000188:drug therapy*
chemical_list: D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate
references.citation: Qual Life Res. 1996 Dec;5(6):521-31
references.pmid: 8993098
references.citation: J Clin Oncol. 2007 Nov 10;25(32):5121-7
references.pmid: 17991931
references.citation: Proc Natl Acad Sci U S A. 1992 Nov 1;89(21):9991-5
references.pmid: 1279685
references.citation: Qual Life Res. 1996 Oct;5(5):469-80
references.pmid: 8973126
references.citation: Acta radiol. 1953 Jan;39(1):73-7
references.pmid: 13030319
references.citation: Radiother Oncol. 1997 Feb;42(2):155-61
references.pmid: 9106924
references.citation: Acta Oncol. 1996;35(8):1021-6
references.pmid: 9023388
references.citation: Acta Radiol Ther Phys Biol. 1965 Apr;3:129-34
references.pmid: 14298788
references.citation: Clin Radiol. 1979 Jul;30(4):397-403
references.pmid: 380872
references.citation: J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10
references.pmid: 11443481
references.citation: Oncol Nurs Forum. 2004 Mar-Apr;31(2):237-47
references.pmid: 15017440
references.citation: Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):809-14
references.pmid: 15183484
references.citation: Cancer Nurs. 2002 Dec;25(6):442-51
references.pmid: 12464836
references.citation: Am J Clin Oncol. 2004 Dec;27(6):626-31
references.pmid: 15577442
references.citation: Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):345-9
references.pmid: 8892458
references.citation: J Clin Oncol. 2007 Nov 10;25(32):5070-7
references.pmid: 17991923
references.citation: Psychosomatics. 1999 Jul-Aug;40(4):309-13
references.pmid: 10402876
references.citation: Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85
references.pmid: 7713781
references.citation: Radiother Oncol. 2004 Nov;73(2):153-62
references.pmid: 15542162
references.citation: Qual Life Res. 1996 Feb;5(1):65-72
references.pmid: 8901368
references.citation: Int J Radiat Oncol Biol Phys. 1993 Jun 15;26(3):413-6
references.pmid: 8514538
references.citation: Radiology. 1982 Jun;143(3):775-7
references.pmid: 7079509
references.citation: Int J Radiat Biol. 1990 Apr;57(4):751-73
references.pmid: 1969905
references.citation: Radiother Oncol. 2001 Jun;59(3):257-65
references.pmid: 11369066
references.citation: Am J Clin Oncol. 2006 Feb;29(1):66-70
references.pmid: 16462506
references.citation: J Invest Dermatol. 1956 May;26(5):361-78
references.pmid: 13332281
references.citation: Strahlentherapie. 1959 Mar;108(3):475-7
references.pmid: 13659285
references.citation: Br J Dermatol. 2002 Jun;146(6):983-91
references.pmid: 12072066
references.citation: Clin Radiol. 1967 Oct;18(4):463-4
references.pmid: 4864308
references.citation: Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10
references.pmid: 11121627
references.citation: Int J Tissue React. 2003;25(1):9-18
references.pmid: 12854882