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NCT Number: NCT02738268

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

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Key information

Conditions

Head Cancer Head and Neck Neoplasms Neck Cancer Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Level Laser Therapy

Device

Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.

Other names: LLLT

sham laser

Device

Primary outcomes

  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 outcomes

  1. VAS-score

    Time frame: 3 months (during radiation therapy and one month after)

    Evaluation of pain using a visual analogue scale (VAS)

  2. Skin dex 16

    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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients

Acronym: DERMISHEAD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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