Head and Neck Cancer Clinical Trial
— CASP-ORLOfficial 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
Verified date | October 2021 |
Source | Jessa Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
Belgium | Jessa Ziekenhuis | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 1 | |
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 14 | |
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 20 | |
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 35 | |
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 38 | |
Other | Clinical photograph | A clinical photograph of the treatment area will be taken | day 47 | |
Other | Personal and medical information | Patient's personal and medical information will be gathered via a patient questionnaire and the patient's medical file | day 1 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 1 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 14 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 20 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 35 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 38 | |
Primary | Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 47 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 1 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 14 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 20 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 35 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 38 | |
Primary | Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 47 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 1 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 14 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 20 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 35 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 38 | |
Secondary | Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 47 | |
Secondary | General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | Day 35 | |
Secondary | General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 38 | |
Secondary | General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 47 |
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