Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

June 27, 2016

Primary Completion Date

November 7, 2019

Study Completion Date

December 9, 2019

Conditions
Hematologic Malignancy
Interventions
DEVICE

Laser treatment

"Patients randomized to the experimental arm receive in addition to mouthwash, preventive treatment of mucositis by LLLT performed by nurses consisting of daily scanning the entire oral cavity for 2 minutes with a power of 250 mW, starting with conditioning and ongoing until the onset of mucositis of grade 1.~If the mucositis is localised, preventive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), preventive laser is stopped for curative laser only."

DEVICE

Placebo

"Patients randomized to the Placebo arm receive in addition to mouthwash fictive laser treatment performed by nurses until the onset of mucositis of grade 1.~If the mucositis is localised, fictive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), fictive laser is stopped for curative laser only."

Trial Locations (3)

42271

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

All Listed Sponsors
collaborator

Hospices Civils de Lyon

OTHER

collaborator

Centre Leon Berard

OTHER

collaborator

Société Biophoton

UNKNOWN

lead

Institut de Cancérologie de la Loire

OTHER

NCT02696408 - Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation | Biotech Hunter | Biotech Hunter