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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04671862
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer

Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers 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.


Condition or disease Intervention/treatment Phase
Mucositis Oral Head and Neck Cancer Radiation Dermatitis Device: Photobiomodulation Not Applicable

Detailed Description:

Introduction: Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy 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 centers 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 radiotherapy and for 1month following radiotherapy

Secondary Objectives

To determine the following during radiotherapy 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Photobiomodulation

Parameters: combined 633nm and 870 nm @1000mW

  • 1 Treatment pre radiotherapy
  • 3 treatments weekly during radiotherapy
Device: Photobiomodulation

Parameters: combined 633nm and 870 nm @1000mW

  • 1 Treatment 4J continuous prior to RT. (Within 14 days of RT start)
  • 3 treatments weekly during RT (6 J at 12 Hz, 80% duty cycle)




Primary Outcome Measures :
  1. Rate of occurence of radiation mucositis [ Time Frame: 7-14 days post radiotherapy ]
    CTCAE version 2.0

  2. Rate of occurence of radiation mucositis [ Time Frame: 1 month post radiotherapy ]
    CTCAE version 2.0

  3. Rate of occurence of radiation mucositis [ Time Frame: 3 months post radiotherapy ]
    CTCAE version 2.0

  4. Rate of occurence of radiation mucositis [ Time Frame: 6 months post radiotherapy ]
    CTCAE version 2.0

  5. Rate of occurence of radiation mucositis [ Time Frame: 12 months post radiotherapy ]
    CTCAE version 2.0

  6. Rate of occurence of radiation mucositis [ Time Frame: 24 months post radiotherapy ]
    CTCAE version 2.0


Secondary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: 7-14 days post radiotherapy ]
    Pain questionnaire

  2. Brief Pain Inventory [ Time Frame: 1 month post radiotherapy ]
    Pain questionnaire

  3. Brief Pain Inventory [ Time Frame: 3 months post radiotherapy ]
    Pain questionnaire

  4. Brief Pain Inventory [ Time Frame: 6 months post radiotherapy ]
    Pain questionnaire

  5. Brief Pain Inventory [ Time Frame: 12 months post radiotherapy ]
    Pain questionnaire

  6. Brief Pain Inventory [ Time Frame: 24 months post radiotherapy ]
    Pain questionnaire

  7. Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) [ Time Frame: 7-14 days post-radiotherapy ]
    Swallowing related quality of life

  8. Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) [ Time Frame: 1 month post-radiotherapy ]
    Swallowing related quality of life

  9. Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) [ Time Frame: 3 months post-radiotherapy ]
    Swallowing related quality of life

  10. Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) [ Time Frame: 12 months post-radiotherapy ]
    Swallowing related quality of life

  11. Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) [ Time Frame: 24 months post-radiotherapy ]
    Swallowing related quality of life

  12. EQ-5D [ Time Frame: 7-14 days post radiotherapy ]
    General Quality of life questionnaire

  13. EQ-5D [ Time Frame: 1 month post radiotherapy ]
    General Quality of life questionnaire

  14. EQ-5D [ Time Frame: 3 months post radiotherapy ]
    General Quality of life questionnaire

  15. EQ-5D [ Time Frame: 6 months post radiotherapy ]
    General Quality of life questionnaire

  16. EQ-5D [ Time Frame: 12 months post radiotherapy ]
    General Quality of life questionnaire

  17. EQ-5D [ Time Frame: 24 months post radiotherapy ]
    General Quality of life questionnaire

  18. Radiation dermatitis [ Time Frame: 7-14 days post radiotherapy ]
    CTCAE version 5.0

  19. Radiation dermatitis [ Time Frame: 1 month post radiotherapy ]
    CTCAE version 5.0

  20. Radiation dermatitis [ Time Frame: 3 months post radiotherapy ]
    CTCAE version 5.0

  21. Radiation dermatitis [ Time Frame: 6 months post radiotherapy ]
    CTCAE version 5.0

  22. Radiation dermatitis [ Time Frame: 12 months post radiotherapy ]
    CTCAE version 5.0

  23. Radiation dermatitis [ Time Frame: 24 months post radiotherapy ]
    CTCAE version 5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
  • Histological diagnosis of head and neck cancer of the oral cavity with no evidence of macroscopic residual disease post-surgery (R0 or R1 resection) and no gross residual lymphadenopathy in the planned PBM treatment area
  • Planned treatment with radiotherapy or chemoradiotherapy to a dose of ≥ 50 Gy
  • ECOG Performance Status of 0 or 1
  • Intact oral mucosa (no visible ulceration, dehiscence or active infection

Exclusion Criteria:

  • Gross macroscopic residual disease post surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
  • Prior radiotherapy to the Head and Neck including the oral or oropharyngeal mucosa.
  • Prior cytotoxic chemotherapy in the last 3 months
  • Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
  • Concurrent administration of Cetuximab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671862


Contacts
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Contact: Ottawa Health Sciences Research Ethics Board 613-798-5555 ext 16719 REBAdministration@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Marc Gaudet, MD MSc MHA    613-737-7700 ext 70206    mgaudet@toh.ca   
Contact: Kristopher Dennis, MD PhD    613-737-7700 ext 70206    krdennis@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04671862    
Other Study ID Numbers: 20190729-01H
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Radiation Injuries
Wounds and Injuries