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

NCT02738268 | Completed

• 1 other identifier: Dermishead-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Cancer; Neck Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

  3 months (during radiation therapy and one month after)

• Radiation Dermatitis Assessment

  radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

  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

  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

  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

  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

  3 months (during radiation therapy and one month after)

Secondary Outcomes (4)

• VAS-score

  3 months (during radiation therapy and one month after)

• Skin dex 16

  3 months (during radiation therapy and one month after)

• Satisfaction with therapy

  3 months (during radiation therapy and one month after)

• moist desquamation

  3 months (during radiation therapy and one month after)

Study Arms (2)

Control group

SHAM COMPARATOR

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

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

Device: Low-level laser therapy

Interventions

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.

Also known as: LLLT

Treatment Group

sham laser DEVICE

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

BE (2)