NCT04671862

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

4.6 years

First QC Date

November 18, 2020

Last Update Submit

February 20, 2024

Conditions

Mucositis OralHead and Neck CancerRadiation Dermatitis

Outcome Measures

Primary Outcomes (6)

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    7-14 days post radiotherapy

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    1 month post radiotherapy

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    3 months post radiotherapy

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    6 months post radiotherapy

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    12 months post radiotherapy

  • Rate of occurence of radiation mucositis

    CTCAE version 2.0

    24 months post radiotherapy

Secondary Outcomes (23)

  • Brief Pain Inventory

    7-14 days post radiotherapy

  • Brief Pain Inventory

    1 month post radiotherapy

  • Brief Pain Inventory

    3 months post radiotherapy

  • Brief Pain Inventory

    6 months post radiotherapy

  • Brief Pain Inventory

    12 months post radiotherapy

  • +18 more secondary outcomes

Study Arms (1)

Photobiomodulation

EXPERIMENTAL

Parameters: combined 633nm and 870 nm @1000mW * 1 Treatment pre radiotherapy * 3 treatments weekly during radiotherapy

Device: Photobiomodulation

Interventions

PhotobiomodulationDEVICE

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)

Photobiomodulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

StomatitisHead and Neck NeoplasmsRadiodermatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasmsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Ottawa Health Sciences Research Ethics Board

CONTACT

613-798-5555REBAdministration@toh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 17, 2020

Study Start

June 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)