NCT02696408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 27, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

February 25, 2016

Last Update Submit

January 28, 2020

Conditions

Hematologic Malignancy

Keywords

MucositisLow level laser therapyAutograftAllograft

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • number of all grades of mucositis

    30 days

  • duration of mucositis

    30 days

  • time of onset of mucositis

    30 days

  • Pain

    30 days

  • Quality of life

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Laser treatment

EXPERIMENTAL

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

laser-off

PLACEBO COMPARATOR

daily laser-off session performed by nurses associated with mouthwashes several times a day (standard preventive treatment of mucositis)

Device: Placebo

Interventions

Laser treatmentDEVICE

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.

Also known as: Oncolase DIGI D5W200
Laser treatment
PlaceboDEVICE

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.

laser-off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing autologous or allogeneic HSC (Hematopoietic Stem Cell) transplantation with myeloablative conditioning
  • Patient affiliated to a social security
  • Signed inform consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Léon Bérard

Lyon, 69373, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMucositis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Emmanuelle TAVERNIER, MD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 2, 2016

Study Start

June 27, 2016

Primary Completion

November 7, 2019

Study Completion

December 9, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)