Clinical trial NCT05175222: Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study
Official title: Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Bone Marrow Transplant Complications
Keywords: oral mucositis
low-level laser therapy
biomodulation
hematopoietic stem cell transplantation
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Fotona d.o.o.
First posted: 2022-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.

Detailed description: This clinical trial is a prospective, randomized open-label study. All patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. Patients who meet the inclusion criteria will be enrolled and randomized into two groups.

Patients in the first group will receive standard supportive treatment. Patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before HSCT. Patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. The procedure will be carried out by trained staff at the bedside.

Severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after HSCT.

Severity of oral mucositis will be assessed according to five-point WHO scale Pain intensity will be measured on the basis of ten-point NRS scale.

In addition, the need for opioid analgesics and total parenteral nutrition will be evaluated.

Photographic documentation will be made on days -7, 0, 7, 14, 21. All obtained results will be collected in a database and subjected to statistical analysis. Additional analysis will be carried out during the study to evaluate whether the differences in results between studied groups reach statistical significance with less than a predetermined number of patients.

Eligibility criteria: Inclusion Criteria:

* written, informed consent for participation in the study
* oral sanation
* myeloablative conditioning

Exclusion Criteria:

* lack of patient's consent
* pathological lesions in oral cavity on the first day of conditioning regimen
* renal failure
* active infection

Primary outcomes:
measure: Duration of oral mucositis
timeFrame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
measure: Severity of oral mucositis
timeFrame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Secondary outcomes:
measure: Need for opioid analgesics calculated
timeFrame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
measure: Length of most severe pain
timeFrame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
state: Pomeranian
Study officials:
affiliation: Medical University of Gdansk
name: Anna Irga-Staniukiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: