Comparing topical Lactokine containing gel with urea cream for prevention and treatment of skin reactions caused by radiotherapy of head and neck cancers.

Phase 2

Recruiting

• Conditions: on-lynphoid cancers of head and neck region.; Malignant neoplasms of lip, oral cavity and pharynx, Malignant neoplasm of nasal cavity and middle ear,Malignant neoplasm of accessory sinuses, Malignant neoplasm of larynx; C00-C14, C

• Registration Number: IRCT2017030632913N1
• Lead Sponsor: Firoozgar Clinical Research Development Center (FCRDC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Cancer of the head and neck region; Proven histology of non-lymphomatoid cancers, Cases receiving at least 60 Gy to target volume; cases at least 18 years old; No active connective tissue disease
exclusion criteria: receiving concurrent target therapy drugs (e.g. cetuximab); previous radiotherapy of head and neck

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and degree of radiodermititis. Timepoint: Visits from the first to the last day of radiotherapy, at least weekly. Method of measurement: CTCAE V.3 radiodermititis grading.

Secondary Outcome Measures

Name	Time	Method
Subjective skin complications. Timepoint: during radiotherapy treatment. Method of measurement: visual metric mesure (0-10) of itching and burning sensation.