Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients (LOMUC)

University of Pavia

Status: Not yet enrolling

Conditions: Hematologic Neoplasms; Oral Mucositis; Head and Neck Neoplasms

Treatments: Device: Ozone therapy; Device: Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07069153

2025-LOMUC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Laser Therapy for Oral Mucositis

Experimental group

Description:

Patients in this arm will undergo high-power diode laser therapy using the Garda Laser LEO PLUS device with a flat-top handpiece at a wavelength of 660 nm. The laser is applied intraorally on the mucosal lesions following a standardized photobiomodulation protocol. The treatment is administered once daily for five consecutive days. Mucositis severity (WHO scale), pain intensity (VAS), and quality of life (OMWQ-HN) will be monitored from baseline through 30 days of follow-up.

Treatment:

Device: Laser Therapy

Ozone Therapy for Oral Mucositis

Active Comparator group

Description:

Patients in this arm will receive medical ozone therapy for the treatment of chemotherapy- or radiotherapy-induced oral mucositis. Ozone is administered intraorally in gaseous form using a Sweden \& Martina DTA device and a flat probe specifically designed for mucosal application. The treatment is delivered once daily for five consecutive days, following a standardized therapeutic protocol. Clinical parameters including mucositis severity (WHO scale), pain (VAS), and quality of life (OMWQ-HN) will be assessed at baseline and during follow-up.

Treatment:

Device: Ozone therapy