Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies (PBM&OM-01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Mucositis; Radiotherapy Side Effect
• Intervention / Treatment: Device: B-Cure laser pro

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saeed Salman, MD; Phone Number: 050-3581987; Email: sa_salman@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
    • Contact: Saeed Salman, MD; Email: sa_salman@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period.	The patients are expected to treat themselves 5 times a week during the 7 week period of radiotherapy, accumulating to a total of 35 treatments. The date of each treatment will be documented in a diary. The number of treatment actually done divided by the 35 expected treatments will be calculated. The outcome is the proportion of patients that will treat themselves at least 18 treatments out of the 35 expected (at least 50%).	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of the patients that will experience severe oral mucositis	The proportion of the patients that will experience severe oral mucositis defined as grade 3 or 4 of the World Health Organization (WHO) grading for oral mucositis, according to the following: Grade 0=the patient has no signs and symptoms; Grade 1=painless ulcers, edema, or mild soreness; Grade 2=painful erythema, edema, or ulcers but able to eat; Grade 3=painful erythema, edema, or ulcers but unable eat; Grade 4=requires parenteral or enteral support	7 weeks

Collaborators and Investigators

• Sponsor: Erika Carmel ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (ACTUAL): January 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: 0183-21-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No