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Mucositis OralPhase 1/2NCT07865780

Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial

A Phase 1/2 study testing sirolase xtent laser and blue m gel in people with Mucositis Oral and Head & Neck Cancer, run by Assiut University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Oral mucositis is the inflammation and ulceration of the mucous membranes within the oral cavity, characterized by atrophy, edema, and erythema (1), and it occurs in nearly all patients with advanced head and neck cancer (HNC) receiving chemotherapy and radiotherapy [2,3]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucositis Oral, Head & Neck Cancer
What is being tested?
sirolase xtent laser and blue m gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
15 Aug 2026to 30 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (≥18 years old) undergoing chemotherapy and/or radiotherapy for head and neck cancers.
  • Adequate general health status to tolerate the procedures (as determined by treating oncologist).

Who cannot join

  • • Presence of severe oral mucositis (Grade IV) requiring enteral or parenteral nutrition.
  • Known allergy or hypersensitivity to components of the topical oxygen gel or contraindications to laser therapy.
  • Uncontrolled systemic diseases (e.g., diabetes mellitus, cardiovascular disease, or severe anemia).
  • Pregnant or lactating women.
  • Patients with photosensitivity disorders or those taking photosensitizing medications.
  • Inability to maintain oral hygiene or attend follow-up visits

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site

  • faculty of dentistry Assiut University

    Asyut, 47471

Other trials in Egypt

About this study

Oral mucositis is the inflammation and ulceration of the mucous membranes within the oral cavity, characterized by atrophy, edema, and erythema (1), and it occurs in nearly all patients with advanced head and neck cancer (HNC) receiving chemotherapy and radiotherapy [2,3]. It can seriously disrupt a person's life, affecting both quality of life and the course of treatment (2).

Identifying the optimal management for oral mucositis remains a significant clinical challenge. Therapeutic modalities such as photobiomodulation (PBM) and benzydamine have shown beneficial effects in reducing mucosal injury and accelerating healing (3). In addition, maintaining proper oral hygiene and using adjunctive therapeutic agents can help minimize mucositis severity. Advanced interventions, including low-level laser therapy and optimized radiation delivery techniques like Intensity-Modulated Radiotherapy, may further reduce the incidence and severity of oral mucosal damage (4).

Read more

PBM can improve tissue regeneration, promote wound healing, and minimize pain and inflammation (5). Patients unable to take non-steroidal anti-inflammatory drugs can benefit from it in addition to enhancing tissue regeneration and post-surgery recovery (6).

Oxygen plays a fundamental role in wound healing, as it is required for cellular energy production, protein synthesis, cell proliferation, angiogenesis, and tissue repair. Oxygen tension varies by anatomical location, and wound sites often remain relatively hypoxic, which increases the risk of infection and ultimately delays or impairs tissue regeneration (7). Consequently, therapeutic strategies aimed at enhancing oxygen availability within the wound environment have been shown to promote more effective wound management and accelerated healing outcomes(8).

Being tested
sirolase xtent laser, blue m gel
Medical subject headings
Stomatitis, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sirolase xtent laserDevice

    SIROLaser Xtend specification Laser type :Diode laser Wavelength:970 nm ± 15 nm Optical power (CW): SIROLaser Xtend: approx. 0.5-5.0 W Peak-pulse: 23 µs fixed 3 sessions a week (MASCC-aligned parameters, e.g., 970 nm, ~40 mW, 2-4 J/cm² per point) from the first RT session (baseline) until the

  • blue m gelDrug

    Aqua, Alcohol, Glycerin, Silica, Sodium Saccharin, Sodium Perborate, Citric Acid, PEG-32, Sodium Gluconate, Lactoferrin, Xanthan Gum, Cellulose Gum

Study groups in NCT07865780
Study groupRoleWhat they receive
photobiomodulation (PBM) only (standard Supportive Care SSC + active PBM)Active comparator* Standard supportive care SSC. * Active PBM (Sirolase): 3 sessions a week (MASCC-aligned parameters, e.g., 970 nm, ~40 mW, 2-4 J/cm² per point) from the first RT session (baseline) until the end of the RT treatment. The anatomical sites irradiated were the right and left buccal mucosa (10 points on each side), upper (4 points) and lower (4 points) labial mucosa, hard palate (3 points),soft palate (3 points), lateral aspects of the tongue (10 points on each side), dorsum of the tongue (3 points), floor of the mouth (2 points), and lip commissure (1point on each side)
Receives: Device: sirolase xtent laser
: PBM + Topical oral oxygen therapy TOOT (SSC + active TOOT + active PBM)Active comparator* SSC as above. * TOOT: blue m oral gel applied to lesions 3×/day (pea-sized ~1 mL/site; do not rinse for ≥30-60 min) from the first RT session (baseline) until the end of the RT treatment * Active PBM as 1st group.
Receives: Device: sirolase xtent laser; Drug: blue m gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of WHO grade

    The severity of OM was assessed using the WHO Oral Toxicity Scale, scored on a 4-grade scale (1, soreness ± erythema; 2, erythema and ulcer, but patient can swallow solid foods; 3, ulcers with extensive erythema and the patient can not swallow food; and 4, mucositis to the extent that alimentation is not possible).

    Measured: Assessments are done at Session 4, Session 7, Session 14, Session 21 and Session 30, which correspond to Day 4, Day 8, Day 17, Day 25 and Day 38.Cycle length is not applicable because this trial uses sessions, not treatment cycles.

Secondary outcomes (1)

  1. VAS

    used to assess treatment response in terms of pain level or burning mouth, which ranged from 0 (no burning) to 10 (severe burning)

    Measured: Assessments are done at Session 4, Session 7, Session 14, Session 21 and Session 30, which correspond to Day 4, Day 8, Day 17, Day 25 and Day 38.Cycle length is not applicable because this trial uses sessions, not treatment cycles.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study start15 Aug 2026
  3. Primary completion20 Sep 2026
  4. Study completion30 Oct 2026 (estimated)

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865780
Sponsor's protocol ID
PBM and TOOT in mucosities
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 1. Raber-Durlacher JE, Elad S, Barasch A. Oral mucositis. Oral Oncol. 2010;46(6):452-6. 2. Shetty SS, Maruthi M, Dhara V, de Arruda JAA, Abreu LG, Mesquita RA, et al. Oral mucositis: Current knowledge and future directions. Disease-a-Month. 2022;68(5):101300. 3. Chaveli-López B, Bagán-Sebastián J V. Treatment of oral mucositis due to chemotherapy. J Clin Exp Dent. 2016;8(2):e201. 4. Moslemi D, Nokhandani AM, Otaghsaraei MT, Moghadamnia Y, Kazemi S, Moghadamnia AA. Management of chemo/radiation-induced oral mucositis in patients with head and neck cancer: A review of the current literature. Radiother Oncol. 2016;120(1):13-20. 5. Sonis ST, Hashemi S, Epstein JB, Nair RG, Raber-Durlacher JE. Could the biological robustness of low level laser therapy (Photobiomodulation) impact its use in the management of mucositis in head and neck cancer patients. Oral Oncol [Internet]. 2016;54:7-14. Available from: http://dx.doi.org/10.1016/j.oraloncology.2016.01.005 6. Cronshaw M, Mylona V. Photobiomodulation therapy within clinical dentistry: theoretical and applied concepts. In: Lasers in dentistry-current concepts. Springer; 2024. p. 173-236. 7. Politis C, Schoenaers J, Jacobs R, Agbaje JO. Wound healing problems in the mouth. Front Physiol. 2016;7:507. 8. Castilla DM, Liu ZJ, Velazquez OC. Oxygen: implications for wound healing. Adv wound care. 2012;1(6):225-30. 9. Barati S, Motevasseli S, Saedi HS, Amiri P, Fekrazad R. Effectiveness of Photobiomodulation (low-level laser therapy) on treatment of oral mucositis (OM) induced by chemoradiotherapy in head and neck cancer patients. J Photochem Photobiol B Biol. 2025;264:113115. 10. Morais MO, Martins AFL, de Jesus APG, de Sousa Neto SS, da Costa AWF, Pereira CH, et al. A prospective study on oral adverse effects in head and neck cancer patients submitted to a preventive oral care protocol. Support Care Cancer. 2020;28(9):4263-73.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing sirolase xtent laser and blue m gel in people with Mucositis Oral and Head & Neck Cancer, run by Assiut University at 1 site in Egypt.

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 2 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. 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 Egypt. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of WHO grade (time frame: Assessments are done at Session 4, Session 7, Session 14, Session 21 and Session 30, which correspond to Day 4, Day 8, Day 17, Day 25 and Day 38.Cycle length is not applicable because this trial uses sessions, not treatment cycles.). 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 NCT07865780, 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 8 Oct 2026.

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