MucositisPBM&OM-01NCT05176834
Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
A study testing B-Cure laser pro in people with Mucositis and Head and Neck Cancer, run by Erika Carmel ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucositis, Head and Neck Cancer, Radiotherapy Side Effect
- What is being tested?
- B-Cure laser pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Jan 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109601
Saeed Salman, MD, sa_salman@rambam.health.gov.il
About this study
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
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
- Being tested
- B-Cure laser pro
- Medical subject headings
- Mucositis, Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Cure laser proDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| B-Cure laser pro | Experimental | 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. Receives: Device: B-Cure laser pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 7 weeks
Secondary outcomes (1)
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
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start31 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erika Carmel ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176834
- Sponsor's protocol ID
- 0183-21-RMB
- Acronym
- PBM&OM-01
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salman S, Abdalla-Aslan R, Awawdi A, Tarabeih R, Billan S. From clinic to couch: a pilot study of home-use photobiomodulation for radiation-induced oral mucositis and dermatitis. Support Care Cancer. 2025 Nov 7;33(12):1023. doi: 10.1007/s00520-025-10037-3.
PubMed 41201561
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05176834
- Acronym / sponsor ID
- PBM&OM-01 / 0183-21-RMB
- Conditions
- Mucositis, Head and Neck Cancer, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erika Carmel ltdUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-Cure laser pro | Experimental | Device: B-Cure laser proIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-Cure laser proThe 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. | Device | B-Cure laser pro |
Primary outcome
Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period.
Time frame: 7 weeks
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%).
1 secondary outcome
The proportion of the patients that will experience severe oral mucositis
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 41201561Salman S, Abdalla-Aslan R, Awawdi A, Tarabeih R, Billan S. From clinic to couch: a pilot study of home-use photobiomodulation for radiation-induced oral mucositis and dermatitis. Support Care Cancer. 2025 Nov 7;33(12):1023. doi: 10.1007/s00520-025-10037-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Cure laser pro in people with Mucositis and Head and Neck Cancer, run by Erika Carmel ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saeed Salman, MD (050-3581987, sa_salman@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.