title: Natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer: a phase 3, double-blind, randomized, controlled trial.
abstract: OBJECTIVE
  To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions.
  
  
  METHODS
  A total of 174 patients were randomized and participated in the study. Patients received either cream 1 (the natural oil-based emulsion containing allantoin) or cream 2 (aqueous cream). Skin toxicity, pain, itching, and skin-related quality of life scores were collected for up to 4 weeks after radiation treatment.
  
  
  RESULTS
  Patients who received cream 1 had a significantly lower average level of Common Terminology Criteria for Adverse Events at week 3 (P<.05) but had statistically higher average levels of skin toxicity at weeks 7, 8, and 9 (all P<.001). Similar results were observed when skin toxicity was analyzed by grades. With regards to pain, patients in the cream 2 group had a significantly higher average level of worst pain (P<.05) and itching (P=.046) compared with the cream 1 group at week 3; however, these differences were not observed at other weeks. In addition, there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 (P=.056). Overall, more participants in the cream 1 group were required to use another topical treatment at weeks 8 (P=.049) and 9 (P=.01).
  
  
  CONCLUSIONS
  The natural oil-based emulsion containing allantoin seems to have similar effects for managing skin toxicity compared with aqueous cream up to week 5; however, it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion (week 6 and beyond). There were no major differences in pain, itching, and skin-related quality of life. In light of these results, clinicians and patients can base their decision on costs and preferences. Overall, aqueous cream seems to be a more preferred option.
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; School of Nursing, Queensland University of Technology, Kelvin Grove, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Australia. Electronic address: email.rchan@gmail.com.
authors.forename: Raymond Javan
authors.initials: RJ
authors.lastname: Chan
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Mann
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Lee
authors.initials: L
authors.lastname: Tripcony
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Jacqui
authors.initials: J
authors.lastname: Keller
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Robyn
authors.initials: R
authors.lastname: Cheuk
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Rae
authors.initials: R
authors.lastname: Blades
authors.affiliation: National Health and Medical Research Council Centre for Research Excellence in Nursing, Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Nathan, Australia.
authors.forename: Samantha
authors.initials: S
authors.lastname: Keogh
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Science and Engineering Faculty, Queensland University of Technology, Brisbane, Australia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Poole
authors.affiliation: Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Walsh
mesh_terms: D000287:Administration, Topical; D000481:Allantoin / Q000008:administration & dosage*; D000704:Analysis of Variance; D001943:Breast Neoplasms / Q000532:radiotherapy; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000737:chemistry; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D057194:Intention to Treat Analysis; D008175:Lung Neoplasms / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011537:Pruritus / Q000628:therapy; D011788:Quality of Life; D011855:Radiodermatitis / Q000473:pathology / Q000517:prevention & control*; D063465:Skin Cream / Q000008:administration & dosage*
chemical_list: D003879:Dermatologic Agents; D004643:Emollients; D000481:Allantoin