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

Hematologic Malignancy Clinical Trial

— STOP MUCITES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696408
• Other study ID #: 2015-07
• Secondary ID: 2015-A01492-47
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2016
• Est. completion date: December 9, 2019

Study information

• Verified date: January 2020
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 9, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Mucositis
• Stomatitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	Centre Hospitalier Lyon Sud	Pierre Bénite
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest en Jarez

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Centre Leon Berard, Hospices Civils de Lyon, Société Biophoton

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of grade 3 mucositis and more	prevalence of grade 3 and more mucositis following the classification proposed by WHO (world health organization)	30 days
Secondary	number of all grades of mucositis	The number of all grades of mucositis will be reported at day 30 post graft for all patients.	30 days
Secondary	duration of mucositis	The duration of mucositis will be reported at day 30 post graft for all patients.	30 days
Secondary	time of onset of mucositis	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	30 days
Secondary	Pain	Pain will be reported for each patient during their participation: 30 days post graft maximum.	30 days
Secondary	Quality of life	Quality of life will be reported for each patient during their participation: 30 days post graft maximum.	30 days
Secondary	Safety	serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.	30 days