Photobiomodulation for Oral Mucositis in Cancer Patients
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
Recruiting
N/AInterventional Study
Oral Mucositis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
30 (estimated)
Sponsor
Peter MacCallum Cancer Centre, Australia · Other
Who this trial is looking for
This trial is looking for patients with oral cancer who are recovering from surgery and will receive radiation treatment. Participants will receive a special light therapy five times a week to see if it helps reduce mouth sores caused by treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with head and neck cancer.
I have no remaining visible cancer after surgery.
I am scheduled to receive radiation treatment of at least 50 Gy.
I have not had previous radiation in the head and neck area.
I have intact oral mucosa with no open sores or infections.
I can provide written consent to participate.
You may not be able to join if
I have remaining cancer or lymph nodes in the treatment area.
I have had chemotherapy in the last 3 months.
I have a photosensitive disorder.
I am pregnant or planning to become pregnant during the trial.
I have epilepsy.
I am receiving the medication cetuximab.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy.
Participants will receive PBM treatment five times a week throughout the course of their radiotherapy.
The main question it aims to answer is whether photobiomodulation reduces the incidence an…
The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy.
Participants will receive PBM treatment five times a week throughout the course of their radiotherapy.
The main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Patient has provided written informed consent using the PBM PICF
* Age ≥ 18 years of age at Screening
* Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological con…
Inclusion Criteria:
* Patient has provided written informed consent using the PBM PICF
* Age ≥ 18 years of age at Screening
* Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area
* Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)
* Intact oral mucosa (no visible ulceration, dehiscence, or active infection)
Exclusion Criteria:
* Gross macroscopic and/or microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
* Prior RT 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
* Known to be pregnant or planning to become pregnant within the trial period
* Diagnosis of epilepsy
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