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Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07387978

Pilot Study of Photobiomodulation to Reduce Oral Mucositis in Oral Cancer Patients Receiving Radiation Therapy

Led by Peter MacCallum Cancer Centre, Australia · Updated on 2026-02-04

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of photobiomodulation PBM, also known as low level laser therapy, on the occurrence and severity of oral mucositis in patients who have undergone surgery for oral cancer and are receiving radiotherapy with or without chemotherapy. This study aims to understand if PBM can reduce oral mucositis, a painful condition affecting the mouth lining during cancer treatment. Participants will receive PBM treatment five times a week during their radiotherapy sessions. After completing radiotherapy, those who still have oral mucositis may continue PBM treatment until the condition resolves, with treatment frequency adjusted by the study team. PBM is applied within and around the oral cavity using a laser device. During the study, participants will be monitored for the development and severity of oral mucositis over about one year. Researchers will also assess pain levels, quality of life, use of pain medication, ability to eat normally, mouth opening restriction trismus, and hospitalization rates. The study includes regular evaluations to track these outcomes and monitor safety throughout the participation period.

CONDITIONS

Brief Title

A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has provided written informed consent using the PBM PICF
  • Age 18 years or older at Screening
  • Histological diagnosis of oral cavity head and neck cancer with no visible disease remaining after surgery (R0 or R1 resection)
  • Planned treatment with radiotherapy or chemoradiotherapy to a dose of 50 Gy or greater
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Intact oral mucosa with no visible ulceration, dehiscence, or active infection
Not Eligible

You will not qualify if you...

  • Visible or microscopic residual disease after surgery (R2 resection) or remaining lymph node enlargement in treatment area
  • Previous radiation therapy to the head and neck including oral or oropharyngeal mucosa
  • Cytotoxic chemotherapy in the last 3 months
  • Diagnosis of photosensitive disorders such as cutaneous porphyria or xeroderma pigmentosum
  • Concurrent use of cetuximab
  • Known pregnancy or planning pregnancy during the study
  • Diagnosis of epilepsy

Research Team

S

Sophie Beaumont, Bachelor of Dental surgery

S

Shae Beaton, Bachelor of oral health

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