A Phase 1/2 interventional study of sirolase xtent laser and blue m gel in Mucositis Oral and Head & Neck Cancer, sponsored by Assiut University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Assiut University · Phase 1/2, Interventional, and Prevention
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).
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).
400 studies on the registry are indexed under Stomatitis; 83 are open to participants now.
This study's planned enrollment of 46 is below the median of 60 across 349 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Presence of severe oral mucositis (Grade IV) requiring enteral or parenteral nutrition.
* 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)
Device: sirolase xtent laser
* 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.
Device: sirolase xtent laser · Drug: blue m gel
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
Aqua, Alcohol, Glycerin, Silica, Sodium Saccharin, Sodium Perborate, Citric Acid, PEG-32, Sodium Gluconate, Lactoferrin, Xanthan Gum, Cellulose Gum
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).
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.
VAS
used to assess treatment response in terms of pain level or burning mouth, which ranged from 0 (no burning) to 10 (severe burning)
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.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Assiut University