Recruiting

Photobiomodulation

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04671862

Conditions

Mucositis Oral

Head and Neck Cancer

Radiation Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation

Study Details

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.

Conditions

Mucositis Oral

Head and Neck Cancer

Radiation Dermatitis

Study ID

NCT04671862

Start date

Jun 1, 2021

Status verified date

Feb, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Photobiomodulation

Parameters: combined 633nm and 870 nm @1000mW

  • 1 Treatment pre radiotherapy
  • 3 treatments weekly during radiotherapy

Interventions

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 measure

  • Rate of occurence of radiation mucositis [ Time Frame: 7-14 days post radiotherapy ]
  • Rate of occurence of radiation mucositis [ Time Frame: 1 month post radiotherapy ]
  • Rate of occurence of radiation mucositis [ Time Frame: 3 months post radiotherapy ]
  • Rate of occurence of radiation mucositis [ Time Frame: 6 months post radiotherapy ]
  • Rate of occurence of radiation mucositis [ Time Frame: 12 months post radiotherapy ]
  • Rate of occurence of radiation mucositis [ Time Frame: 24 months post radiotherapy ]

Central Contacts and Locations

Central contacts

Ottawa Health Sciences Research Ethics Board

613-798-5555REBAdministration@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Marc Gaudet, MD MSc MHA

613-737-7700mgaudet@toh.ca

Kristopher Dennis, MD PhD

613-737-7700krdennis@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-02-21.