None listed
Conditions
Brief summary
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, such as 40-60% of breast and head and neck cancer patients is high enough to cause severe reactions. 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 in breast cancer patients in New Zealand showed that soft silicone dressings decreased skin reaction severity (1–4). The skin dose received by breast cancer patients was less than 40Gy. However, a small pilot study in NZ head and neck cancer patients receiving a higher skin dose (>45Gy) suggested that Mepitel Film was less effective. The aim of this trial is to determine in a larger cohort how effective Mepitel Film is in preventing and managing acute skin reactions caused by radiation therapy to cancer in the head and neck region. We used the preliminary results from the head and neck pilot study to recruit enough patients to be able to see a statistically significant decrease of 30% in skin reaction severity as measured by RISRAS trial. References 1. Diggelmann K, Zytkovicz A, Tuaine J, Bennett N, Kelly L, Herst P. Brit J Radiol [Internet]. 2010 Nov [cited 2012 May 9];83(995):971–8. 2. Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, et al. J Cancer Sci Ther [Internet]. 2012 [cited 2013 Jul 3];04(11):347–56. 3. Herst P, Bennet N, Sutherland A, Peszynski R, Paterson D, Jasperse M. Radiother Oncol., 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005. 4. Herst P. J Med Radiat Sci [Internet]. 2014 Jun 28 [cited 2014 Jul 4];61(2):119–25.
Interventions
Mepitel Film is applied from day one of radiation therapy until the end of the trial (4 weeks after completion of radiation therapy) or until moist desquamation occurs. If moist desquamation occurs then these skin areas 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 by 10 cm with a uniformly high dose (>30Gy). This area will be divided into two similar halve
Mepitel Film is applied from day one of radiation therapy until the end of the trial (4 weeks after completion of radiation therapy) or until moist desquamation occurs. If moist desquamation occurs then these skin areas 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 by 10 cm with a uniformly high dose (>30Gy). This area will be divided into two similar halves, one half will be randomized to Mepitel Film and the other to a moisturising control cream. Mepitel Film will be applied by the researcher (a radiation therapist or radiation oncologist) and replaced only when necessary (when the film curls up too much).
Sponsors
Otago University
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 for 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