N/A
Completed N=68
Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis
Source: ClinicalTrials.gov NCT02050373 ↗Enrolled (actual)
68
Serious AEs
16.2%
Results posted
Jan 2021
Primary outcomePrimary: Severity of Oral Mucositis — 27; 24; 0; 0 Participants — p=<0.05
Summary
The aim of the study is to evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of LLLT in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Oral Mucositis |
27; 24; 0; 0; 0; 0 | <0.05 sig |
| SECONDARY Level of Inflammatory Mediators |
1733; 185; 730; 201; 1264; 195 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen;
Exclusion Criteria
- Patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the HSCT Unit.
Data sourced from ClinicalTrials.gov (NCT02050373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.