Does Mepitel Film decrease skin reactions caused by radiation therapy in head and neck cancer patients?

Phase 2

• Conditions: Acute radiation-induced skin reactions; Head and Neck Cancer; Cancer - Head and neck; Skin - Other skin conditions

• Registration Number: ACTRN12616000725460
• Lead Sponsor: Otago University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 86

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

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
Time to development of moist desquamation. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.[The number of days after the start of radiation therapy until moist desquamation develops.<br>Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.];Time to healing of moist desquamation. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.[Number of days that moist desquamation is present. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.]