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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
Sponsor:
Collaborators:
Hospices Civils de Lyon
Centre Leon Berard
Société Biophoton
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hematologic Malignancy Device: Laser treatment Device: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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)
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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. duration of mucositis [ Time Frame: 30 days ]
    The duration of mucositis will be reported at day 30 post graft for all patients.

  3. 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

  4. Pain [ Time Frame: 30 days ]
    Pain will be reported for each patient during their participation: 30 days post graft maximum.

  5. Quality of life [ Time Frame: 30 days ]
    Quality of life will be reported for each patient during their participation: 30 days post graft maximum.

  6. Safety [ Time Frame: 30 days ]
    serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Emmanuelle TAVERNIER, MD 04 77 91 70 60 ext +33 emmanuelle.tavernier@icloire.fr
Contact: Isabelle JEANDET, Nurse 04 77 91 74 05 ext +33 isabelle.jeandet@icloire.fr

Locations
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France
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       sophie.ducastelle-lepretre@chu-lyon.fr   
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    emmanuelle.tavernier@icloire.fr   
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         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Hospices Civils de Lyon
Centre Leon Berard
Société Biophoton
Investigators
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Principal Investigator: Emmanuelle TAVERNIER, MD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT02696408     History of Changes
Other Study ID Numbers: 2015-07
2015-A01492-47 ( Other Identifier: ANSM )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut de Cancérologie de la Loire:
Mucositis
Low level laser therapy
Autograft
Allograft
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases