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Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials

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Abstract

Purpose

This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs).

Methods

Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4.

Results

Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2–3 RD (odds ratio (OR), 0.24; 95% CI, 0.09–0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10–0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, − 2.56; 95% CI, − 3.15 to − 1.96, p < 0.00001; SMD for researcher ratings, − 3.47; 95% CI, − 6.63 to − 0.31, p = 0.03; SMD for combined scores, − 3.68; 95% CI, − 6.43 to − 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence.

Conclusion

While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2–3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film’s efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms.

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Data availability

The datasets analyzed for this meta-analysis have been obtained from publicly available sources.

Code availability

The statistical code and computational methods employed in this meta-analysis are available upon reasonable request.

References

  1. Barton MB, Jacob S, Shafiq J, Wong K, Thompson SR, Hanna TP, Delaney GP (2014) Estimating the demand for radiotherapy from the evidence: a review of changes from 2003 to 2012. Radiother Oncol 112:140–144

    Article  PubMed  Google Scholar 

  2. Bolderston A, Lloyd NS, Wong RK, Holden L, Robb-Blenderman L (2006) The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline. Support Care Cancer 14:802–817

    Article  PubMed  Google Scholar 

  3. Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P, Behroozian T, Goldshtein D, Ryan Wolf J et al (2023) MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part (1) systematic review. eClinicalMedicine 58:101886

    Article  PubMed  PubMed Central  Google Scholar 

  4. Leventhal J, Young MR (2017) Radiation dermatitis: recognition, prevention, and management. Oncology 31(885-887):894–889

    Google Scholar 

  5. Rzepecki A, Birnbaum M, Ohri N, Daily J, Fox J, Bodner W, Kabarriti R, Garg M, Mehta K, Kalnicki S, McLellan BN (2022) Characterizing the effects of radiation dermatitis on quality of life: a prospective survey-based study. J Am Acad Dermatol 86:161–163

    Article  PubMed  Google Scholar 

  6. Singh M, Alavi A, Wong R, Akita S (2016) Radiodermatitis: a review of our current understanding. Am J Clin Dermatol 17:277–292

    Article  PubMed  Google Scholar 

  7. Herst PM, Bennett NC, Sutherland AE, Peszynski RI, Paterson DB, Jasperse ML (2014) 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 110:137–143

    Article  CAS  PubMed  Google Scholar 

  8. Møller PK, Olling K, Berg M, Habæk I, Haislund B, Iversen AM, Ewertz M, Lorenzen EL, Brink C (2018) Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - a Danish intra-patient randomized multicentre study. Tech Innov Patient Support Radiat Oncol 7:20–25

    Article  PubMed  PubMed Central  Google Scholar 

  9. Behroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C et al (2023) Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: a randomized multicenter open-label phase III trial. J Clin Oncol 41:1250–1264

    Article  CAS  PubMed  Google Scholar 

  10. Herst PM (2014) Protecting the radiation-damaged skin from friction: a mini review. J Med Radiat Sci 61:119–125

    Article  PubMed  PubMed Central  Google Scholar 

  11. Wooding H, Yan J, Yuan L, Chyou T-Y, Gao S, Ward I, Herst PM (2018) The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. Br J Radiol 91:20170298

    Article  PubMed  Google Scholar 

  12. Anderson G, Ebadi M, Vo K, Novak J, Govindarajan A, Amini A (2021) An updated review on head and neck cancer treatment with radiation therapy. Cancers 13:4912

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Bressan V, Stevanin S, Bianchi M, Aleo G, Bagnasco A, Sasso L (2016) The effects of swallowing disorders, dysgeusia, oral mucositis and xerostomia on nutritional status, oral intake and weight loss in head and neck cancer patients: a systematic review. Cancer Treat Rev 45:105–119

    Article  PubMed  Google Scholar 

  14. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S et al (2021) The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372:n71

    Article  PubMed  PubMed Central  Google Scholar 

  15. Higgins JPT, Green S Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from https://www.cochrane-handbook.org/. Accessed 24 June 2023

  16. Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savović J, Schulz KF, Weeks L, Sterne JAC (2011) The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343:d5928

    Article  PubMed  PubMed Central  Google Scholar 

  17. Guyatt G, Gutterman D, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips B, Raskob G, Lewis SZ, Schünemann H (2006) Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest 129:174–181

    Article  PubMed  Google Scholar 

  18. Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327:557–560

    Article  PubMed  PubMed Central  Google Scholar 

  19. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177–188

    Article  CAS  PubMed  Google Scholar 

  20. Yan J, Yuan L, Wang J, Li S, Yao M, Wang K, Herst PM (2020) Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial. J Med Radiat Sci 67:208–216

    Article  PubMed  PubMed Central  Google Scholar 

  21. Rades D, Narvaez CA, Splettstößer L, Dömer C, Setter C, Idel C, Ribbat-Idel J, Perner S, Bartscht T, Olbrich D, Schild SE, Carl J (2019) A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). Radiother Oncol 139:79–82

    Article  PubMed  Google Scholar 

  22. Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, Herst P (2012) Randomized intra-patient controlled trial of mepilex lite dressings versus aqueous cream in managing radiation-induced skin reactions postmastectomy. J Cancer Sci Ther 4:347–356

    Article  Google Scholar 

  23. Dejonckheere CS, Dejonckheere E, Layer JP, Layer K, Sarria GR, Koch D, Abramian A, Kaiser C, Lindner K, Bachmann A, Anzböck T, Röhner F, Schmeel FC, Schmeel LC (2023) Barrier films for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomised controlled trials. Breast 71:31–41. https://doi.org/10.1016/j.breast.2023.07.001

    Article  PubMed  PubMed Central  Google Scholar 

  24. Chan RJ, Blades R, Jones L, Downer TR, Peet SC, Button E, Wyld D, McPhail S, Doolan M, Yates P (2019) A single-blind, randomised controlled trial of StrataXRT® - a silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer. Radiother Oncol 139:72–78

    Article  CAS  PubMed  Google Scholar 

  25. O’Dell K, Kearney R (2018) Feasibility study: use of a silicone gel in head and neck skin care. Journal of Medical Radiation Sciences 65:99–113

    Google Scholar 

  26. Rutten LI (2018) Feasibility of Strata XRT in the treatment of radiation dermatitis in head and neck cancer patients (Thesis, Bachelor of Radiation Therapy with Honours). University of Otago

    Google Scholar 

  27. Hindley A, Zain Z, Wood L, Whitehead A, Sanneh A, Barber D, Hornsby R (2014) Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: results of a randomized trial. Int J Radiat Oncol Biol Phys 90:748–755

    Article  CAS  PubMed  Google Scholar 

  28. Ho AY, Olm-Shipman M, Zhang Z, Siu CT, Wilgucki M, Phung A, Arnold BB, Porinchak M, Lacouture M, McCormick B, Powell SN, Gelblum DY (2018) 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 101:325–333

    Article  CAS  PubMed  Google Scholar 

  29. Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA (2011) 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. Int J Radiat Oncol Biol Phys 79:1460–1466

    Article  CAS  PubMed  Google Scholar 

  30. Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC (2011) Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys 81:397–402

    Article  PubMed  Google Scholar 

  31. Liao Y, Feng G, Dai T, Long F, Tang J, Pu Y, Zheng X, Cao S, Xu S, Du X (2019) Randomized, self-controlled, prospective assessment of the efficacy of mometasone furoate local application in reducing acute radiation dermatitis in patients with head and neck squamous cell carcinomas. Medicine 98:e18230

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  32. Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G (2000) Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys 48:1307–1310

    Article  CAS  PubMed  Google Scholar 

  33. Fenig E, Brenner B, Katz A, Sulkes J, Lapidot M, Schachter J, Malik H, Sulkes A, Gutman H (2001) Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncol Rep 8:305–309

    CAS  PubMed  Google Scholar 

  34. Szumacher E, Wighton A, Franssen E, Chow E, Tsao M, Ackerman I, Andersson L, Kim J, Wojcicka A, Ung Y, Sixel K, Hayter C (2001) Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. Int J Radiat Oncol Biol Phys 51:81–86

    Article  CAS  PubMed  Google Scholar 

  35. Momm F, Bartelt S, Haigis K, Grosse-Sender A, Witucki G (2005) Spectrophotometric skin measurements correlate with EORTC/RTOG-common toxicity criteria. Strahlenther Onkol 181:392–395

    Article  PubMed  Google Scholar 

  36. Böhner AMC, Koch D, Schmeel FC, Röhner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC (2020) Objective evaluation of risk factors for radiation dermatitis in whole-breast irradiation using the spectrophotometric L*a*b color-space. Cancers 12:2444

    Article  PubMed  PubMed Central  Google Scholar 

  37. Schmeel LC, Koch D, Stumpf S, Leitzen C, Simon B, Schüller H, Vornholt S, Schoroth F, Müdder T, Röhner F, Garbe S, Schmeel FC, Schild HH, Wilhelm-Buchstab TM (2018) Prophylactically applied Hydrofilm polyurethane film dressings reduce radiation dermatitis in adjuvant radiation therapy of breast cancer patients. Acta Oncol 57:908–915

    Article  CAS  PubMed  Google Scholar 

  38. Schmeel LC, Koch D, Schmeel FC, Bücheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Brüser D, Abramian AV, Schoroth F, Müdder T, Röhner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM (2019) Hydrofilm polyurethane films reduce radiation dermatitis severity in hypofractionated whole-breast irradiation: an objective, intra-patient randomized dual-center assessment. Polymers 11:2112

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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Authors and Affiliations

  1. Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore, 119228, Singapore

    Shing Fung Lee & Francis C. H. Ho

  2. Department of Clinical Oncology, Tuen Mun Hospital, New Territories West Cluster, Hospital Authority, Tuen Mun, Hong Kong

    Shing Fung Lee & Adrian Wai Chan

  3. Department of Oncology, Princess Margaret Hospital, Kwai Chung, Hong Kong

    Henry C. Y. Wong

  4. Cancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPO), Florence, Italy

    Saverio Caini

  5. Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Saba Shariati, Samantha K. F. Kennedy & Edward Chow

  6. Department of Radiation Oncology, University of Lübeck, Lübeck, Germany

    Dirk Rades

  7. Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, Australia

    Raymond J. Chan

  8. Departments of Dermatology and Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA

    Julie Ryan Wolf

  9. Research and Development Department, Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands

    Corina van den Hurk

  10. Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada

    Tara Behroozian

  11. Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy

    Pierluigi Bonomo

  12. Department of Radiation Therapy, University of Otago, Wellington, New Zealand

    Patries Herst

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Contributions

Shing Fung Lee and Henry Wong performed title and abstract screening, full-text screening, resolved conflicts in screening, and data extraction. Adrian Wai Chan, Saba Shariati, Samantha Kennedy, and Dirk Rades assisted with systematic review, analyses, and draft of manuscript. Tara Behroozian, Pierluigi Bonomo, and Francis C. H. Ho provided expertise on methodology, interpretation of results, and revision of manuscript drafts. Edward Chow and Patries Herst are senior authors of the manuscript and provided oversight for the whole project. Shing Fung Lee wrote the main manuscript text and prepared all figures and tables. Saverio Caini helped prepare figures. Julie Ryan Wolf and Corina van den Hurk are co-Chairs of MASCC Oncodermatology Study Group and assisted with revision of manuscript for final version, as well as supportive oversight for the project. All authors edited the manuscript and provided comments. All authors have read and approved the final version.

Corresponding author

Correspondence to Shing Fung Lee.

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Not applicable for systematic review and meta-analysis.

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Not applicable for systematic review and meta-analysis.

Conflict of interest

Edward Chow received the free supply of StrataXRT in a pilot study of StrataXRT in the prevention of radiation dermatitis in breast cancer. Raymond J. Chan received funding support from Moogoo and Stratpharma to conduct clinical trials and delivering educational sessions in relation to prevention and management of radiation dermatitis. Julie Ryan Wolf receives coauthor royalties from UpToDate for radiation dermatitis article. All other authors have no relevant financial or non-financial interests to disclose.

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Lee, S.F., Wong, H.C.Y., Chan, A.W. et al. Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 31, 527 (2023). https://doi.org/10.1007/s00520-023-07988-w

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