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

Primary Purpose

Head Cancer, Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Low-level laser therapy
sham laser
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control group

Treatment Group

Arm Description

Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Outcomes

Primary Outcome Measures

Radiation Dermatitis Grade
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)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of trans epidermal water loss of the skin
Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Objective measurement of the skin hydration
Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of degree of erythema of the skin
Mexameter MX18 will be used to objectively measure the degree of erythema of the skin
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA

Secondary Outcome Measures

VAS-score
Evaluation of pain using a visual analogue scale (VAS)
Skin dex 16
Health-related quality of life measure specific to skin diseases (Skindex-16)
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
moist desquamation
Onset time of moist desquamation

Full Information

First Posted
April 11, 2016
Last Updated
August 31, 2021
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02738268
Brief Title
Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients
Acronym
DERMISHEAD
Official Title
Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Cancer, Neck Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Intervention Type
Device
Intervention Name(s)
Low-level laser therapy
Other Intervention Name(s)
LLLT
Intervention Description
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.
Intervention Type
Device
Intervention Name(s)
sham laser
Primary Outcome Measure Information:
Title
Radiation Dermatitis Grade
Description
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)
Time Frame
3 months (during radiation therapy and one month after)
Title
Radiation Dermatitis Assessment
Description
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time Frame
3 months (during radiation therapy and one month after)
Title
Objective measurement of trans epidermal water loss of the skin
Description
Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
Time Frame
3 months (during radiation therapy and one month after)
Title
Objective measurement of the skin hydration
Description
Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Time Frame
3 months (during radiation therapy and one month after)
Title
Objective measurement of degree of erythema of the skin
Description
Mexameter MX18 will be used to objectively measure the degree of erythema of the skin
Time Frame
3 months (during radiation therapy and one month after)
Title
Analyze the skin cytokine content of the irradiated and non-irradiated breast
Description
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Time Frame
3 months (during radiation therapy and one month after)
Secondary Outcome Measure Information:
Title
VAS-score
Description
Evaluation of pain using a visual analogue scale (VAS)
Time Frame
3 months (during radiation therapy and one month after)
Title
Skin dex 16
Description
Health-related quality of life measure specific to skin diseases (Skindex-16)
Time Frame
3 months (during radiation therapy and one month after)
Title
Satisfaction with therapy
Description
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time Frame
3 months (during radiation therapy and one month after)
Title
moist desquamation
Description
Onset time of moist desquamation
Time Frame
3 months (during radiation therapy and one month after)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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