Clinical trial · Interventional
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis Oral | — | UNRESOLVED | — |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photobiomodulation
- description
- Parameters: combined 633nm and 870 nm @1000mW * 1 Treatment pre radiotherapy * 3 treatments weekly during radiotherapy
- interventionNames
- Device: Photobiomodulation
Primary outcomes (6)
- measure
- Rate of occurence of radiation mucositis
- timeFrame
- 7-14 days post radiotherapy
- description
- CTCAE version 2.0
- measure
- Rate of occurence of radiation mucositis
- timeFrame
- 1 month post radiotherapy
- description
- CTCAE version 2.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available