Head and Neck Neoplasms, Hematologic Neoplasms, Oral Mucositis
Conditions
Keywords
Oral Mucositis, Cancer Pain, Laser Therapy, Ozone Therapy, Photobiomodulation, Head and Neck Cancer, Hematologic Malignancies, Chemotherapy, Radiotherapy, Supportive Care in Oncology
Brief summary
This randomized clinical trial aims to compare the efficacy of laser therapy and ozone therapy in the treatment of oral mucositis in adult cancer patients undergoing chemotherapy or radiotherapy, particularly those with head and neck tumors or hematologic malignancies. Oral mucositis is a frequent and debilitating complication of cancer treatment, characterized by painful ulcerations that impair nutrition, speech, and oral hygiene, often requiring opioid analgesics and supportive care. Forty eligible patients will be randomly assigned to two parallel groups. The trial group will receive high-power diode laser therapy using a flat-top handpiece at 660 nm wavelength, following a standardized photobiomodulation protocol. The control group will be treated with medical ozone gas administered via an intraoral device, using a standardized ozone therapy protocol. Both treatments will be applied once daily over five consecutive days. Patients will be followed up at 15 and 30 days after treatment initiation. The primary outcome is the reduction in mucositis severity, measured using the World Health Organization (WHO) Oral Toxicity Scale. Secondary outcomes include pain intensity assessed with the Visual Analogue Scale (VAS), and quality of life evaluated through the Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN). The study seeks to determine whether laser therapy offers superior clinical benefits compared to ozone therapy in reducing lesion severity, alleviating pain, and improving patient well-being during cancer treatment.
Interventions
DEVICELaser Therapy
High-power diode laser therapy is applied to the oral mucosa using the Garda Laser LEO PLUS device with a flat-top handpiece at 660 nm wavelength. Treatment is delivered once daily over five consecutive days according to a standardized photobiomodulation protocol (energy density: 2-4 J/cm²).
DEVICEOzone therapy
Medical ozone gas is delivered intraorally using the Sweden & Martina DTA device. The treatment is administered once daily over five consecutive days. A flat-tipped probe is used to apply ozone directly to the mucosal lesions at a concentration of 30-40 µg/mL, following a standardized safety protocol.
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of head and neck cancer or hematologic malignancy * Currently undergoing chemotherapy and/or radiotherapy * Presence of oral mucositis of grade 2 or higher (WHO Oral Mucositis Scale) * Ability to provide written informed consent * Willingness to comply with study procedures and follow-up schedule
Exclusion criteria
* Presence of autoimmune or systemic diseases affecting the oral mucosa (e.g., lichen planus, pemphigus, pemphigoid) * Presence of active oral infections unrelated to mucositis (e.g., candidiasis, herpes simplex) * Previous treatment with ozone or laser therapy for oral mucositis in the past 3 months * Pregnancy or breastfeeding * Cognitive impairment or psychiatric disorders preventing full cooperation * Known allergy or intolerance to ozone or laser exposure * Use of investigational drugs or participation in other clinical trials within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Mucositis Severity Assessed by WHO Oral Mucositis Scale | Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5) | Oral mucositis severity will be evaluated using the World Health Organization (WHO) Oral Mucositis Scale, a standardized clinical tool that grades mucosal toxicity on a scale from 0 to 4. Grade 0 indicates no mucositis, grade 1 indicates soreness and erythema, grade 2 denotes erythema and ulcers but the patient can eat solid food, grade 3 represents ulcers with a liquid diet only, and grade 4 corresponds to severe mucositis with alimentation not possible. Scores will be recorded at baseline (T0), after 5 days of treatment (T1), and at follow-up visits on day 15 (T3) and day 30 (T5). The primary endpoint is the change in WHO score from baseline to day 30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Assessed by Visual Analogue Scale (VAS) | Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5) | Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will be instructed to mark the point that best represents their current level of oral pain. VAS scores will be collected at baseline (T0), after each treatment session (T1-T5), and at follow-up visits on day 15 (T3) and day 30 (T5). |
| Change in Quality of Life Assessed by Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN) | Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5) | Quality of life will be assessed using the validated Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN), a patient-reported outcome tool developed for individuals receiving radiotherapy or chemotherapy for head and neck cancer. The questionnaire includes 13 items covering oral pain, swallowing, speaking, eating, use of medications, and impact on daily life. Each item is scored on a 0 to 4 Likert scale, where 0 = Not at all and 4 = Extremely. The overall OMWQ-HN score is calculated by summing all item scores, with total values ranging from 0 to 52. Higher scores indicate a greater negative impact on quality of life due to oral mucositis. The questionnaire will be administered at baseline (T0) and at day 30 (T5), allowing comparison of quality of life before and after treatment. |
Countries
Italy
Outcome results
None listed