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

Primary Purpose

Mucositis, Head and Neck Cancer, Radiotherapy Side Effect

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
B-Cure laser pro
Sponsored by
Erika Carmel ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mucositis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B-Cure laser pro

Arm Description

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.

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2021
Last Updated
February 8, 2022
Sponsor
Erika Carmel ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05176834
Brief Title
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
Acronym
PBM&OM-01
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erika Carmel ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Head and Neck Cancer, Radiotherapy Side Effect

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B-Cure laser pro
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
B-Cure laser pro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period.
Description
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%).
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
The proportion of the patients that will experience severe oral mucositis
Description
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
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with malignant neoplasm in the oral cavity, pharynx or salivary glands. 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. A patient with an ECOG PS functional status equal to or less than 2 Able to read and understand the informed consent form (ICF) and voluntarily provided informed consent The patient is able to undergo intra-oral treatments The patient is willing to perform the protocol. Exclusion Criteria: The patient underwent previous radiation to the current therapeutic field The patient has health conditions of the teeth or mouth that will prevent the application of intra-oral treatment The patient receives non-standard treatment for mucositis such as benzidamine, palifermin, etc. The patient is enrolled to any other clinical trial that includes treatment or intervention that may affect the course of mucositis. The patient has a diagnosis that affects the healing of wounds (eg diabetes, lupus, etc.) Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saeed Salman, MD
Phone
050-3581987
Email
sa_salman@rambam.health.gov.il
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saeed Salman, MD
Email
sa_salman@rambam.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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