Clinical trial NCT05176834: Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mucositis
Head and Neck Cancer
Radiotherapy Side Effect
Lead sponsor: Erika Carmel ltd
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period.
timeFrame: 7 weeks
Secondary outcomes:
measure: The proportion of the patients that will experience severe oral mucositis
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References: