Radiation dermatitis (RD) remains one of the most common adverse effects, affecting the majority of patients receiving radiotherapy.1,2 Despite the advances in radiotherapy techniques, our recent clinical trials indicated as many as 85% of patients (with mixed-cancer type) undergoing radiotherapy experienced dry desquamation, and 15% of patients experienced moist desquamation, requiring wound dressing.1 These proportions were even higher in patients receiving treatment to their head and neck.3 Given the high prevalence of RD, much attention and resources have been invested into research to identify the best solution to manage and resolve this adverse effect.
The first randomized controlled trial (RCT) on RD prevention and management can be traced back to 1962, conducted in the United Kingdom, which investigated the effects of steroid and antibiotic ointment versus antibiotic control ointment versus no ointment on the severity of RD.4 Since then, the literature on RD prevention and management has been growing and has been “overcrowded.” As our research team embarked on a program of research in this area in 2010, we decided to apply a systematic approach to ensure we were addressing the most pertinent issue and a true research gap. In 2012, we published an overview of systematic reviews, which collated, critically appraised, and summarized the findings from 6 systematic reviews that examined interventions for preventing or managing RD.5 This overview reported significant variability in the quality and scope of reviews and suggested that methodological flaws might have biased subsequent practice recommendations. Based on these findings, our team conducted a large systematic review and meta-analysis6 of 47 studies including 5688 participants. In this review, we concluded that, despite the high number of trials in this area, there was insufficient evidence of effectiveness to recommend any single intervention for prevention or management of RD due to limited high-quality, comparative research providing definitive results.6 The negative findings, including a negative RCT1 conducted by our team published in 2014, were discouraging to both the clinical and research community. At this time, we, the research community, had to ask ourselves a very difficult question: What went wrong and what should be our next steps? There was recognition that perhaps the previous research over the last 50 years was not truly conducted with sufficient novel biological rationale.7
More recently, there have been breakthroughs in this research area, with several encouraging, positive trials suggesting the efficacy of certain topical corticosteroids2 and silicone-based film dressings.8–10 This includes our own recently completed RCT (n = 197)3 that reported significant effectiveness of a silicone-based, film-forming gel dressing in preventing and reducing both dry desquamation and moist desquamation in patients receiving radiotherapy to their head and neck. To the best of our knowledge, this RCT is the first definitive trial to yield significant, positive effects of nonsteroidal topical preparation for RD in patients with head and neck cancer.10 The distinct difference between these latter, positive trials and the previous, negative trials was that the interventions used in the latter trials clearly addressed an underlying biological mechanism, with sufficient level of anticipated effectiveness.
From the lessons learned from the 50 years of literature on RD prevention and management, I would like to humbly propose several recommendations for the research community to consider in the conduct of interventional research, especially in any “overcrowded” area of research. First, all researchers should undertake a systematic approach (ie, a systematic review) to identify the true research gap, including understanding and postulating why the previous strategies did not work and what holds promise. Second, to ensure the success of our research, our interventions must address promising, underlying relevant mechanisms. Third, considering patient burden and the current stringent research funding climate with a limited research funding pool, the research community has the responsibility to ensure our research investment is put toward the most significant and promising work that will ultimately improve the well-being of people affected by cancer.
My very best,
Raymond Javan Chan, PhD, MAppSc (Research), BN, RN
Princess Alexandra Hospital, Metro South Hospital and Health Service, Queensland; and School of Nursing,
Queensland University of Technology, Brisbane, Australia
1. Chan RJ, Mann J, Tripcony L, et al. 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. Int J Radiat Oncol Biol Phys
2. Ho AY, Olm-Shipman M, Zhang Z, et al. A randomized trial of mometasone furoate 0.1% to reduce high-grade acute radiation dermatitis in breast cancer patients receiving postmastectomy radiation. Int J Radiat Oncol Biol Phys
3. Chan R, Blades R, Jones L, Button E, Wyld D, Yates P. A single-blind, randomized controlled trial of StrataXRT®—a silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patient with head and neck cancer. Oncol Nurs Forum
4. Halnan KE. The effect of corticosteroids on the radiation skin reaction. A random trial to assess the value of local application of prednisolone and neomycin ointment after x-ray treatment of basal cell carcinoma. Br J Radiol
5. Chan RJ, Larsen E, Chan P. Re-examining the evidence in radiation dermatitis management literature: an overview and a critical appraisal of systematic reviews. Int J Radiat Oncol Biol Phys
6. Chan RJ, Webster J, Chung B, Marquart L, Ahmed M, Garantziotis S. Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials. BMC Cancer
7. Freedman GM. Topical agents for radiation dermatitis in breast cancer: 50 shades of red or same old, same old? Int J Radiat Oncol Biol Phys
8. Herst PM, Bennett NC, Sutherland AE, Peszynski RI, Paterson DB, Jasperse ML. Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiother Oncol
9. Wooding H, Yan J, Yuan L, et al. The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. Br J Radiol Jan
10. Ferreira EB, Vasques CI, Gadia R, et al. Topical interventions to prevent acute radiation dermatitis in head and neck cancer patients: a systematic review. Support Care Cancer