Effectiveness of an phythetapic in prevention and treatment of skin lesions caused by radiotherapy in patients with Head and Neck Cancer
Phase 3
Recruiting
- Conditions
- C17.800.174.826Head and Neck Cancer
- Registration Number
- RBR-237v4b
- Lead Sponsor
- Hospital Erasto Gaertner - HEG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Age above 18 years,diagnosis of cancer and head and neck radiotherapy, intact skin and continuous in the head and neck, first day of radiotherapy (if new), patients with no previous history of radiotherapy in the same field / local radiation,
Consent to participate in by signing the consent form (ICF).
Exclusion Criteria
Previous reports of allergic reaction in the use of one of the research products (essential fatty acids or marigold).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development radiodermitis grade 1. Expected results: prove that Marigold is more effective than the essential fatty acids (EFA) in the prevention and treatment of radiodermitis in patients with head and neck cancer undergoing radiotherapy. The evaluation was according to the criteria of the Radiation Therapy Oncology Group (RTOG) which graduates from 0 to 4 with radiodermatitis. Radiodermatitis was assessed on the first day of radiotherapy, the five sessions and 30 days after the end of treatment, in order to observe its presence and evolution.;Outcomes observed: the degree radiodermitis 1 emerged from the tenth day of radiotherapy, with the highest incidence in the control group (AGE).
- Secondary Outcome Measures
Name Time Method Development radiodermitis grade 2, grade 3 or grade 4.;Outcomes observed: control group had a higher incidence of grade 2 radiodermitis compared with the experimental group.