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
Phase 2
Completed
- Conditions
- Acute radiation-induced skin reactionsCancer of the Head and Neck regionCancer - Head and neckSkin - Other skin conditions
- Registration Number
- ACTRN12614000932662
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin reaction severity as determined by Radiation Induced Skin Reaction Assessment Scale (RISRAS) or Radiation Therapy Oncology Group (RTOG) score.[RISRAS and RTOG scores will be determined 3x a week from the moment of faint erythema till the end of radiation treatment and once a week for 4 weeks after completion of radiation therapy.]
- Secondary Outcome Measures
Name Time Method Percentage of patients who develop moist desquamation either in the control area and/or in the treatment area and the time it takes for moist desquamation to develop.[Time to development of moist desquamation.];Effect of psychosocial stress on skin reaction severity as determined by validated Distress Thermometer.[This measures will be used at baseline and weekly after that.];Time to healing of moist desquamation[Number of days it takes for the moist desquamation to heal]