Clinical trial · Interventional
Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation
Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation : a Randomized Double Blind Multicenter Prospective Phase III Trial
- 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)
The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated lesions. There are little data in the literature showing its efficacy in prevention of mucositis in cohorts of patients with hematopoietic stem cells transplantation. The main objective of this study is to assess the efficacy of a prophylactic low level laser therapy performed by nurses on the severity of oral mucositis during HSCT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser treatment | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser treatment
- description
- preventive treatment performed by nurses of mucositis by laser treating daily by scanning the entire oral cavity for 2 minutes with a power of 250 mW associated with mouthwashes several times a day (standard preventive treatment of mucositis)
- interventionNames
- Device: Laser treatment
- type
- PLACEBO_COMPARATOR
- label
- laser-off
- description
- daily laser-off session performed by nurses associated with mouthwashes several times a day (standard preventive treatment of mucositis)
- interventionNames
- Device: Placebo
Primary outcomes (1)
- measure
- prevalence of grade 3 mucositis and more
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient undergoing autologous or allogeneic HSC (Hematopoietic Stem Cell) transplantation with myeloablative conditioning * Patient affiliated to a social security * Signed inform consent Exclusion Criteria: * Patient undergoing HSCT (Hematopoietic Stem Cell Transplantation) with reduced intensity conditioning Slavin (FB2) or Seattle (F-2 Gy TBI) * Protected major patient * Pregnant woman * Patient with pacemaker * Epileptic Patient
References
Publications (0)
Data not yet available