Head CancerDERMISHEADNCT02738268
Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients
A study testing Low-level laser therapy in people with Head Cancer and Neck Cancer, run by Hasselt University at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head Cancer, Neck Cancer
- What is being tested?
- Low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, 3600
Jessa Ziekenhuis
Hasselt, 3500
About this study
Official title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
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.
- Conditions
- Head Cancer, Neck Cancer
- Being tested
- Low-level laser therapy, sham laser
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyDevice
Also called LLLT
Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.
sham laserDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy Receives: Device: sham laser |
| Treatment Group | Experimental | Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy Receives: Device: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months (during radiation therapy and one month after)
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Measured: 3 months (during radiation therapy and one month after)
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
Measured: 3 months (during radiation therapy and one month after)
Objective measurement of the skin hydration
Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Measured: 3 months (during radiation therapy and one month after)
Objective measurement of degree of erythema of the skin
Mexameter MX18 will be used to objectively measure the degree of erythema of the skin
Measured: 3 months (during radiation therapy and one month after)
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
Measured: 3 months (during radiation therapy and one month after)
Secondary outcomes (4)
VAS-score
Evaluation of pain using a visual analogue scale (VAS)
Measured: 3 months (during radiation therapy and one month after)
Skin dex 16
Health-related quality of life measure specific to skin diseases (Skindex-16)
Measured: 3 months (during radiation therapy and one month after)
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Measured: 3 months (during radiation therapy and one month after)
moist desquamation
Onset time of moist desquamation
Measured: 3 months (during radiation therapy and one month after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Prof. dr. Jeroen Mebis, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738268
- Sponsor's protocol ID
- Dermishead-001
- Acronym
- DERMISHEAD
- Status last verified
- Aug 2021
- First submitted
- 11 Apr 2016
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT02738268
- Acronym / sponsor ID
- DERMISHEAD / Dermishead-001
- Conditions
- Head Cancer, Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: sham laserControl group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
| Treatment Group | Experimental | Device: Low-level laser therapyTreatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level laser therapyAlso: LLLTLow-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care. | Device | Treatment Group |
| sham laser | Device | Control group |
Primary outcome
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)
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)
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
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
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
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
4 secondary outcomes
VAS-score
Time frame: 3 months (during radiation therapy and one month after)
Skin dex 16
Time frame: 3 months (during radiation therapy and one month after)
Satisfaction with therapy
Time frame: 3 months (during radiation therapy and one month after)
moist desquamation
Time frame: 3 months (during radiation therapy and one month after)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Head Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy in people with Head Cancer and Neck Cancer, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dermatitis Grade (time frame: 3 months (during radiation therapy and one month after)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.