Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

Titre officiel

Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiation Therapy for Head and Neck Cancer

Sommaire:

La radiothérapie pour le cancer de la tête et du cou peut provoquer une mucosite (ulcères dans la bouche) et des douleurs graves. La photobiomodulation (luminothérapie) sera utilisée avant et pendant la radiothérapie pour tenter de réduire l’apparition et la gravité de la mucosite chez les patients traités par radiothérapie pour un cancer de la tête et du cou. Des études antérieures menées chez des patients atteints d’un cancer de la tête et du cou ont montré que la photobiomodulation (luminothérapie) peut prévenir la mucosite. Aucun centre au Canada n’utilise actuellement cette technique en tant que pratique courante, mais elle est recommandée dans les directives internationales et largement utilisée en Europe. Les chercheurs souhaitent donc mettre en œuvre cette technique à Ottawa dans le cadre d’un essai clinique afin de s’assurer de sa sécurité et de son efficacité dans un contexte canadien.

Description de l'essai

Primary Outcome:

  • Rate of occurence of radiation mucositis
  • Rate of occurence of radiation mucositis
  • Rate of occurence of radiation mucositis
  • Rate of occurence of radiation mucositis
  • Rate of occurence of radiation mucositis
  • Rate of occurence of radiation mucositis
Secondary Outcome:
  • Brief Pain Inventory
  • Brief Pain Inventory
  • Brief Pain Inventory
  • Brief Pain Inventory
  • Brief Pain Inventory
  • Brief Pain Inventory
  • Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
  • Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
  • Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
  • Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
  • Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
  • EQ-5D
  • EQ-5D
  • EQ-5D
  • EQ-5D
  • EQ-5D
  • EQ-5D
  • Radiation dermatitis
  • Radiation dermatitis
  • Radiation dermatitis
  • Radiation dermatitis
  • Radiation dermatitis
  • Radiation dermatitis
Introduction: Radiation Therapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiation therapy to try to reduce the occurence and severity of mucositis in patients treated with radiation therapy for head and neck cancer Rationale: Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centres in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context. Purpose/Objectives: Primary Objective Primary Objective • To determine the cumulative incidence of acute mucositis as defined by CTCAE version 2.0 for radiation induced mucositis (Appendix 1) during radiation therapy and for 1month following radiation therapy Secondary Objectives To determine the following during radiation therapy and for 24 months post-treatment
  • Rate of occurrence of acute radiation dermatitis
  • Pain scores
  • Opioid use
  • ESAS scores during and after RT
  • FACT-HN questionnaire scores
  • Late subcutaneous neck fibrosis
  • Late mucosal and skin telangiectasia Study design/methodology: This is single arm prospective cohort study of a single intervention (photobiomodulation) in patients with head and neck cancer for the prevention of oral mucositis. Outcomes will be the following:
  • Rates of acute and late mucositis according to CTCAE version 2.0
  • Rates of acute and late dermatitis and fibrosis according to CTCAE version 5.0
  • Rates of late teleangiectasia
  • Pain scores as per Edmonton Symptom assessment scale (ESAS) and modified brief pain inventory
  • Rates of opioid use
  • FACT-HN scores
  • EQ5D scores Anticipated public/scientific benefit: This study aims to study the use of Photobiomodulation treatments for prevention of oral mucositis. This is recommended in international guidelines but not used in routine practice in Canada. The benefit of this study is to allow implemetation of this technique in the Canadian context in a controlled and evaluated manner. This will hopefully then allow further study and wider implementation of this technique both in Ottawa and in Canada

Voir cet essai sur ClinicalTrials.gov

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