NCT05176834

Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies

Self-applied Photobiomodulation Therapy With a Home-use Device for the Prevention and/or Acceleration of Healing of Radiation-induced Oral Mucositis in Patients With Head and Neck Malignancies - A Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Erika Carmel ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with head and neck malignancy that are treated with Radiation Therapy \[RT\] are expected to develop Oral Mucositis (OM) in 60% of cases. Mucositis is a side effect of radiation and / or chemotherapy that causes severe pain and inability to eat and drink and a decrease in quality of life. In addition it may impair the treatment protocol and treatment outcomes. Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics. The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.

Conditions

• Mucositis
• Head and Neck Cancer
• Radiotherapy Side Effect

Interventions

Type	Name	Description
DEVICE	B-Cure laser pro	The B-Cure laser pro is a portal, non-invasive, photobiomodulation device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 1J/cm2.

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-01-04
• Last updated: 2022-02-24

Locations

1 site across 1 country: Israel