Clinical trial NCT02696408: Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematologic Malignancy
Keywords: Mucositis
Low level laser therapy
Autograft
Allograft
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: Centre Leon Berard
name: Société Biophoton
First posted: 2016-03-02
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: prevalence of grade 3 mucositis and more
timeFrame: 30 days
Secondary outcomes:
measure: number of all grades of mucositis
timeFrame: 30 days
measure: duration of mucositis
timeFrame: 30 days
measure: time of onset of mucositis
timeFrame: 30 days
measure: Pain
timeFrame: 30 days
measure: Quality of life
timeFrame: 30 days
measure: Safety
timeFrame: 30 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Emmanuelle TAVERNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: