Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Jessa Hospital
- Locations
- 2
- Primary Endpoint
- Radiodermatitis grading
Overview
Brief Summary
Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx.
- •Scheduled for bilateral neck radiotherapy (\>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
- •Signed written informed consent
Exclusion Criteria
- •Previous irradiation to the head and/or neck region
- •Metastatic disease
- •Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- •Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
- •Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- •Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
- •Patients using high doses of non-steroidal anti-inflammatory drugs
- •Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant
Outcomes
Primary Outcomes
Radiodermatitis grading
Time Frame: Day 47
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis severity
Time Frame: Day 47
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Secondary Outcomes
- General satisfaction(day 47)
- Quality of life measurement(day 47)