Clinical trial NCT04593914: A Novel Skin Barrier Protectant for Acute Radiodermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Radiodermatitis
Radiation Toxicity
Radiation Dermatitis
Skin Diseases
Head and Neck Cancer
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiodermatitis grading
timeFrame: Day 1
measure: Radiodermatitis grading
timeFrame: Day 14
measure: Radiodermatitis grading
timeFrame: Day 20
measure: Radiodermatitis grading
timeFrame: Day 35
measure: Radiodermatitis grading
timeFrame: Day 38
measure: Radiodermatitis grading
timeFrame: Day 47
measure: Radiodermatitis severity
timeFrame: Day 1
measure: Radiodermatitis severity
timeFrame: Day 14
measure: Radiodermatitis severity
timeFrame: Day 20
measure: Radiodermatitis severity
timeFrame: Day 35
measure: Radiodermatitis severity
timeFrame: Day 38
measure: Radiodermatitis severity
timeFrame: Day 47
Secondary outcomes:
measure: Quality of life measurement
timeFrame: day 1
measure: Quality of life measurement
timeFrame: day 14
measure: Quality of life measurement
timeFrame: day 20
measure: Quality of life measurement
timeFrame: day 35
measure: Quality of life measurement
timeFrame: day 38
measure: Quality of life measurement
timeFrame: day 47
measure: General satisfaction
timeFrame: Day 35
measure: General satisfaction
timeFrame: day 38
measure: General satisfaction
timeFrame: day 47
Other outcomes:
measure: Clinical photograph
timeFrame: day 1
measure: Clinical photograph
timeFrame: day 14
measure: Clinical photograph
timeFrame: day 20
measure: Clinical photograph
timeFrame: day 35
measure: Clinical photograph
timeFrame: day 38
measure: Clinical photograph
timeFrame: day 47
measure: Personal and medical information
timeFrame: day 1
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: Limburgs Oncologisch Centrum
name: Annelies Maes, MD
role: PRINCIPAL_INVESTIGATOR
References: