A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients.
Janielle K-A Taylor, Leila J Mady, Khalil Baddour...
https://pubmed.ncbi.nlm.nih.gov/36474663Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07387978
A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment
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
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
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
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Throughout the course of radiotherapy
Participants receive photobiomodulation (low level laser therapy) five times a week during their course of radiation treatment.
Five visits per week (in-person)
Implementation
Duration - Duration varies until oral mucositis resolution
If oral mucositis persists after radiotherapy, participants may continue photobiomodulation treatment until oral mucositis resolves, with frequency determined by the investigator.
Visit frequency at investigator's discretion
Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
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Research Team
S
Sophie Beaumont, Bachelor of Dental surgery
S
Shae Beaton, Bachelor of oral health
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Published Research Related To This Trial
Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis.
Herve Y Sroussi, Joel B Epstein, Rene-Jean Bensadoun...
https://pubmed.ncbi.nlm.nih.gov/29071801Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer: first report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study.
Andrew Macann, Tsien Fua, Chris G Milross...
https://pubmed.ncbi.nlm.nih.gov/24521675MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.
Sharon Elad, Karis Kin Fong Cheng, Rajesh V Lalla...
https://pubmed.ncbi.nlm.nih.gov/32786044Mechanisms of PhotoBioModulation (PBM) focused on oral mucositis prevention and treatment: a scoping review.
Elodie Courtois, Wafa Bouleftour, Jean-Baptiste Guy...
https://pubmed.ncbi.nlm.nih.gov/33926421Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses.
Thaís Bianca Brandão, Karina Morais-Faria, Ana Carolina Prado Ribeiro...
https://pubmed.ncbi.nlm.nih.gov/29423682Safety and efficacy of photobiomodulation therapy in oncology: A systematic review.
René-Jean Bensadoun, Joel B Epstein, Raj G Nair...
https://pubmed.ncbi.nlm.nih.gov/33107198