CompletedPhase 2ACTRN12614000932662

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


Sponsor

University of Otago

Enrollment

30 participants

Start Date

May 15, 2015

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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

Exclusion Criteria6

  • 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

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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 mo

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.


Locations(2)

Christchurch, New Zealand

China

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ACTRN12614000932662