Clinical trial · Interventional
Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT
Effectiveness of Extraoral Photobiomodulation Protocols in Management of Oral Adverse Effects in Patients Undergoing Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients undergoing hematopoietic cell transplantation (HSCT) receive high doses of chemotherapy with or without radiotherapy to eradicate the underlying disease, which induces a series of adverse effects, including in the oral cavity. Among the most common oral lesions is oral mucositis (OM), which has been associated with greater morbidity and important biological and economic impact.Currently, photobiomodulation (PBM) with intraoral application has been recommended for the prevention of OM, however, few studies have evaluated the impact of its extraoral use.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.80 |
| Hyposalivation | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation therapy (extraoral) | Device | — | UNRESOLVED |
| Photobiomodulation therapy (intraoral) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intraoral photobiomodulation (PBMI)
- description
- The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present. PBMI protocol will use the indium-gallium-aluminium-phosphorus diode laser (InGaAlP) (DUO® - MMOptics Ltda, São Carlos, Brazil). Four anatomical areas will be irradiated perpendicularly in the buccal mucosa through several anatomical points with a distance of approximately 1 cm between them, in order to cover the largest area per cm² by region. Application points: * Buccal mucosa: 9 points each side: bite line on cheeks and upper and lower internal buccal vestibule (18 points). * Tongue: 4 points on each side, on the lateral and ventral edge (8 points). * Floor of the mouth: 1 point on each side (2 points) * Upper and lower lips: upper and lower lips (lip redness), bottom of upper and lower sulcus and buccal commissure, right and left sides (4 points). * Soft palate: right and left side (2 points)
- interventionNames
- Device: Photobiomodulation therapy (intraoral)
- type
- ACTIVE_COMPARATOR
- label
- Extraoral photobiomodulation (PBME)
- description
- The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present. A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm, previously standardized and calibrated for extraoral application by the measurement of potency (Coherent Inc, Santa Clara, CA). The equipment will be programmed with 1 W of power. The application points will be carried out perpendicularly on the face. Application points: * 4 points on each cheek (2 on the right and 2 on the left) * 1 on lips; patients with sealed lips being possible to cover the upper and lower lip * 5 points in the cervical region (2 in the right submandibular space and 2 in the left submandibular space and submental space in the midline).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 and scheduled for autologous or allogeneic HSCT. * Patients undergoing myeloablative conditioning regimen Exclusion Criteria: * Patients previously submitted to autologous or allogeneic HSCT * Patients on a non-myeloablative conditioning regimen * Patients on a reduced-intensity conditioning regimen
References
Publications (0)
Data not yet available