Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation (STOP MUCITES)
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|ClinicalTrials.gov Identifier: NCT02696408|
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : June 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancy||Device: Laser treatment Device: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||June 27, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
Experimental: 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)
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.
Other Name: Oncolase DIGI D5W200
Placebo Comparator: laser-off
daily laser-off session performed by nurses associated with mouthwashes several times a day (standard preventive treatment of mucositis)
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.
- prevalence of grade 3 mucositis and more [ Time Frame: 30 days ]prevalence of grade 3 and more mucositis following the classification proposed by WHO (world health organization)
- number of all grades of mucositis [ Time Frame: 30 days ]The number of all grades of mucositis will be reported at day 30 post graft for all patients.
- duration of mucositis [ Time Frame: 30 days ]The duration of mucositis will be reported at day 30 post graft for all patients.
- time of onset of mucositis [ Time Frame: 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
- Pain [ Time Frame: 30 days ]Pain will be reported for each patient during their participation: 30 days post graft maximum.
- Quality of life [ Time Frame: 30 days ]Quality of life will be reported for each patient during their participation: 30 days post graft maximum.
- Safety [ Time Frame: 30 days ]serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696408
|Contact: Emmanuelle TAVERNIER, MD||04 77 91 70 60 ext +email@example.com|
|Contact: Isabelle JEANDET, Nurse||04 77 91 74 05 ext +firstname.lastname@example.org|
|Centre Léon Bérard||Not yet recruiting|
|Lyon, France, 69373|
|Contact: Emmanuelle Nicolas-Virelizier, MD Emmanuelle.NICOLAS-VIRELIZIER@lyon.unicancer.fr|
|Principal Investigator: Emmanuelle Nicolas-Virelizier, MD|
|Sub-Investigator: Souad Assaad, MD|
|Sub-Investigator: Amine Belhabri, MD|
|Sub-Investigator: Lila Gilis, MD|
|Sub-Investigator: Laure Lebras, MD|
|Sub-Investigator: Anne-Sophie Michallet, MD|
|Sub-Investigator: Philippe Rey, MD|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre Bénite, France, 69495|
|Contact: Sophie Ducastelle, PhD email@example.com|
|Sub-Investigator: Gilles Salles, MD|
|Principal Investigator: Sophie Ducastelle, MD|
|Sub-Investigator: Fiorenza Barraco, MD|
|Sub-Investigator: Hélène Labussière, MD|
|Sub-Investigator: Etienne Paubelle, MD|
|Sub-Investigator: Xavier Thomas, MD|
|Sub-Investigator: Eric Wattel, MD|
|Sub-Investigator: Mauricette Michallet, MD|
|Sub-Investigator: Clément Rocher, MD|
|Sub-Investigator: Marie-Virginie Larcher, MD|
|Institut de Cancérologie Lucien Neuwirth||Recruiting|
|Saint-Priest en Jarez, France, 42271|
|Contact: Emmanuelle Tavernier, PhD 04 77 91 70 60 ext +33 firstname.lastname@example.org|
|Principal Investigator: Emmanuelle Tavernier, MD|
|Sub-Investigator: Jérôme Cornillon, MD|
|Sub-Investigator: Denis Guyotat, MD|
|Sub-Investigator: Fressia Honeyman, MD|
|Sub-Investigator: Caroline Lejeune, MD|
|Principal Investigator:||Emmanuelle TAVERNIER, MD||Institut de Cancérologie Lucien Neuwirth|