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The effect of Mepitel Film on skin reaction severity and moist desquamation rates in patients undergoing radiation therapy for head and neck cancer: a pilot study

The effect of Mepitel Film compared with sorbolene cream on acute radiation-induced skin reaction severity and moist desquamation rates in patients undergoing radiation therapy for head and neck cancer: a randomized intra-patient controlled pilot study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000932662
Enrollment
36
Registered
2014-09-01
Start date
2015-05-15
Completion date
2016-12-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background External beam irradiation is a common treatment option for most solid cancers. Although the skin of all patients receives a certain amount of radiation, the skin dose in patients with tumours close to the skin is high enough to cause severe reactions (moist desquamation). This is the case for 40-60% of breast and head and neck cancer patients. Severe skin reactions can be very painful and affect patient quality of life as well as increasing the chance of developing infections. Our previous three skin trials showed that soft silicone dressings decreased skin reaction severity in breast cancer patients in New Zealand (1–3). The dressings adhere closely to the folds and creases of the skin and prevent friction damage (due to items of clothing or other skin parts) to the radiation damaged skin (4). Damage protection by the dressings is best when they are used from the start of radiation treatment, resulting in a 90% reduction of skin reaction severity and a complete lack of moist desquamation (3). However, using dressings from the start of radiation treatment is not always practical. If started when the skin shows faint erythema (redness), the dressings decrease skin reaction severity up to 40% but do not affect moist desquamation rates (1,2). Mepitel Film has so far only been used in the preventative setting in breast cancer patients who received a skin dose of less than 40Gy. In addition to investigating the effect of Mepitel Film, we also want to measure the effect of patient stress levels on skin reaction severity. Our previous trial showed that breast cancer patients who are highly stressed during their course of radiation therapy have a much higher chance of developing moist desquamation. We wish to confirm these findings in a cohort of head and neck cancer patients. References 1. Diggelmann K, Zytkovicz A, Tuaine J, Bennett N, Kelly L, Herst P. Mepilex Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial. Brit J Radiol [Internet]. 2010 Nov [cited 2012 May 9];83(995):971–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20647511 2. Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, et al. Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Postmastectomy. J Cancer Sci Ther [Internet]. 2012 [cited 2013 Jul 3];04(11):347–56. Available from: http://www.omicsonline.org/1948-5956/JCST-04-347.digital/JCST-04-347.html 3. Herst P, Bennet N, Sutherland A, Peszynski R, Paterson D, Jasperse M. Prophylactic use of Mepitel Film completely prevents radiation-induced moist desquamation in an intra-patient controlled RCT of 78 breast cancer patients in New Zealand. Radiother Oncol. 2014;in press. 4. Herst P. Protecting the radiation-damaged skin from friction: a mini review. J Med Radiat Sci [Internet]. 2014 Jun 28 [cited 2014 Jul 4];61(2):119–25. Available from: http://doi.wiley.com/10.1002/jmrs.46

Interventions

We changed the intervention from a management. to a prophylactic trial. The film is now applied from day one of radiation therapy until the end of the trial or until moist desquamation occurs. If moist desquamation occurs then these patches will be covered by the standard dressing that is used in each department. The skin area of interest will be identified from the treatment plans and comprise of a skin area of at least 5 cm2 with a uniform high dose (>40Gy). Thi sarea will be divided into tw

We changed the intervention from a management. to a prophylactic trial. The film is now applied from day one of radiation therapy until the end of the trial or until moist desquamation occurs. If moist desquamation occurs then these patches will be covered by the standard dressing that is used in each department. The skin area of interest will be identified from the treatment plans and comprise of a skin area of at least 5 cm2 with a uniform high dose (>40Gy). Thi sarea will be divided into two similar halves, one half will be randomized to film and the other to cream.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

patients receiving radiation and chemoradiation squamous cell carcinoma of the oropharynx, nasopharynx and oral cavity

Exclusion criteria

Radiation or chemoradiation <30Gy Distant metastatic disease Previous radiation to the head and neck area Skin consitions that may aggrevate radiation-induced skin reactions Karnofski score<70% Patients with facial hair on the treatment site

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026