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

NCT ID: NCT05176834

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

B-Cure laser pro

In case of appearance of mucositis, patients will receive standard treatment as usual (rinses, painkillers, etc.). In addition, study participants will treat themselves with the B-Cure laser pro before each radiation therapy session at the clinic and will continue with daily treatment until the disappearance of the mucositis should it develop.

Group Type: EXPERIMENTAL

B-Cure laser pro

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with malignant neoplasm in the oral cavity, pharynx or salivary glands.

2. The patient should receive a continuous course of radiation therapy (IMRT) with all of the following criteria applicable:

• For a period of 3-7 weeks, 5-6 fractions per week.
• A minimum cumulative dose of 30Gy expected to cause OM (ORAL MUCOSITIS) by the third week. Or: Based on the clinical judgment of the Radiation Oncologist and BED2 ≥ 30 Gy
• The treatment field will include at least one oral site (buccal mucosa, floor of mouth, tongue, hard palate, retro-molar trigon, lips or oropharynx)
• With or without chemotherapy and / or immunotherapy at the same time.

3. A patient with an ECOG PS functional status equal to or less than 2

4. Able to read and understand the informed consent form (ICF) and voluntarily provided informed consent

5. The patient is able to undergo intra-oral treatments

6. The patient is willing to perform the protocol.

Exclusion Criteria

1. The patient underwent previous radiation to the current therapeutic field

2. The patient has health conditions of the teeth or mouth that will prevent the application of intra-oral treatment

3. The patient receives non-standard treatment for mucositis such as benzidamine, palifermin, etc.

4. The patient is enrolled to any other clinical trial that includes treatment or intervention that may affect the course of mucositis.

5. The patient has a diagnosis that affects the healing of wounds (eg diabetes, lupus, etc.)

6. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erika Carmel ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Saeed Salman, MD

Role: CONTACT

sa_salman@rambam.health.gov.il

050-3581987

Facility Contacts

Saeed Salman, MD

Role: primary

sa_salman@rambam.health.gov.il

Other Identifiers

0183-21-RMB

Identifier Type: -

Identifier Source: org_study_id