Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation
- Conditions
- Hematologic Malignancy
- Interventions
- Device: Laser treatmentDevice: Placebo
- Registration Number
- NCT02696408
- Lead Sponsor
- Institut de Cancérologie de la Loire
- Brief Summary
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.
- Detailed Description
The main end point for efficacy is the reduction of severe mucositis (grade 3 or more). The secondary efficacy endpoints are the reduction of mucositis, whatever the grade, the reduction of time with mucositis, the time to onset of mucositis symptoms, the reduction of pain intensity and evaluation of quality of life.The secondary endpoints for safety are severe adverse events and potential toxicity. Patients will be allocated at inclusion with a 1/1 ratio either to laser-on or laser-off groups. In the laser group, patients will undergo laser therapy performed by nurses, which will consist of irradiation of the whole oral cavity during 2 minutes with 250mW power. In the laser-off group, laser therapy will be carried out with equipment off during the same time, and still performed by nurses. Protective eye shields will be used to avoid detrimental effects on eyes and to keep the subjects blind.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- Patient undergoing autologous or allogeneic HSC (Hematopoietic Stem Cell) transplantation with myeloablative conditioning
- Patient affiliated to a social security
- Signed inform consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laser treatment Laser treatment 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) laser-off Placebo daily laser-off session performed by nurses associated with mouthwashes several times a day (standard preventive treatment of mucositis)
- Primary Outcome Measures
Name Time Method prevalence of grade 3 mucositis and more 30 days prevalence of grade 3 and more mucositis following the classification proposed by WHO (world health organization)
- Secondary Outcome Measures
Name Time Method Pain 30 days Pain will be reported for each patient during their participation: 30 days post graft maximum.
Quality of life 30 days Quality of life will be reported for each patient during their participation: 30 days post graft maximum.
time of onset of mucositis 30 days time of onset of mucositis will be assessed by measuring the interval between the beginning of packaging and the first day of mucositis has been assessed at a grade 1
number of all grades of mucositis 30 days The number of all grades of mucositis will be reported at day 30 post graft for all patients.
Safety 30 days serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.
duration of mucositis 30 days The duration of mucositis will be reported at day 30 post graft for all patients.
Trial Locations
- Locations (3)
Centre Léon Bérard
🇫🇷Lyon, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint-Priest en Jarez, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite, France