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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Ottawa Health Sciences Research Ethics Board
REBAdministration@toh.ca
613-798-5555
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Photobiomodulation
Parameters: combined 633nm and 870 nm @1000mW~* 1 Treatment pre radiotherapy~* 3 treatments weekly during radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov