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Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients (DERMISHEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738268
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Prof. dr. Jeroen Mebis, Hasselt University

Brief Summary:

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.


Condition or disease Intervention/treatment Phase
Head Cancer Neck Cancer Device: Low-level laser therapy Device: sham laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Sham Comparator: Control group
Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Device: sham laser
Experimental: Treatment Group
Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Device: Low-level laser therapy
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.
Other Name: LLLT




Primary Outcome Measures :
  1. Radiation Dermatitis Grade [ Time Frame: 3 months (during radiation therapy and one month after) ]
    objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

  2. Radiation Dermatitis Assessment [ Time Frame: 3 months (during radiation therapy and one month after) ]
    radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  3. Objective measurement of trans epidermal water loss of the skin [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

  4. Objective measurement of the skin hydration [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration

  5. Objective measurement of degree of erythema of the skin [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Mexameter MX18 will be used to objectively measure the degree of erythema of the skin

  6. Analyze the skin cytokine content of the irradiated and non-irradiated breast [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA


Secondary Outcome Measures :
  1. Pain [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Evaluation of pain using a visual analogue scale (VAS)

  2. Quality of life [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Health-related quality of life measure specific to skin diseases (Skindex-16)

  3. Satisfaction with therapy [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis

  4. moist desquamation [ Time Frame: 3 months (during radiation therapy and one month after) ]
    Onset time of moist desquamation



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 radiotherapy (>60 Gy), chemo-irradiation or bio-radiation 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738268


Contacts
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Contact: Jeroen Mebis, prof. dr. jeroen.mebis@jessazh.be
Contact: Jolien Robijns, drs. jolien.robijns@uhasselt.be

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Jolien Robijns, drs.    +32 11 30 99 89    jolien.robijns@uhasselt.be   
Principal Investigator: Annelies Maes, MD         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Jolien Robijns, drs.       jolien.robijns@uhasselt.be   
Contact: Jeroen Mebis, prof.dr.       jeroen.mebis@jessazh.be   
Principal Investigator: Jeroen Mebis, prof. dr.         
Sponsors and Collaborators
Hasselt University
Jessa Hospital
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Responsible Party: Prof. dr. Jeroen Mebis, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02738268    
Other Study ID Numbers: Dermishead-001
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Radiodermatitis
Neoplasms by Site
Neoplasms
Dermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries