Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer (NCT07724444) | Clinical Trial Compass
CompletedNot Applicable
Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer
Italy40 participantsStarted 2024-09-25
Plain-language summary
This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life.
The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed.
The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available.
The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Histologically confirmed diagnosis of a malignant neoplasm of the head and neck region.
* Receipt of radiotherapy, chemotherapy, or concurrent chemoradiotherapy for head and neck cancer.
* Clinically documented oral mucositis of World Health Organization grade 1 or higher.
* Previous treatment of oral mucositis with either laser therapy or ozone therapy as part of routine clinical care.
* Availability of baseline oral mucositis severity assessment and at least one post-treatment assessment.
* Availability of sufficient clinical records to determine eligibility and evaluate the study outcomes.
Exclusion Criteria:
* Active oral infection at the time of oral mucositis assessment, including oral candidiasis or herpes simplex infection.
* Use of another specific treatment for oral mucositis within the 2 weeks before initiation of laser therapy or ozone therapy, when documented.
* Medical conditions contraindicating laser therapy or ozone therapy, including photosensitivity disorders or severe respiratory disease.
* Concurrent participation in another interventional clinical study that could have affected oral mucositis outcomes.
* Pregnancy or breastfeeding at the time of treatment, when documented.
* Neurological, psychiatric, or cognitive conditions that could have impaired reliable pain assessment or questionnaire completion.
* Previous treatment with both laser therapy and ozone therapy during the same episode of oral m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale
Timeframe: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).