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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis; Bone Marrow Transplant Complications
• Intervention / Treatment: Radiation: Laser therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomeranian
    • Gdańsk, Pomeranian, Poland, 80-210
      • Medical University of Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser; Patients receive low-level laser therapy with LightWalker laser from the first day of conditioning chemotherapy till +2 day post hematopoietic stem cell transplantation. Additionally, standard supportive care is introduced.	Radiation: Laser therapy; Patients receive laser therapy in 7 points in oral cavity every day from the first day of conditioning chemotherapy till the second day post HSCT. Each point is irradiated for 1 minute.
NO_INTERVENTION: Control; Patients are observed and receive standard supportive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of oral mucositis	Duration of oral mucositis duration in days measured in both groups	First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Severity of oral mucositis	Evaluation of pain according to NRS scale	First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for opioid analgesics calculated	Opioid analgesic need assessed in days	First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Length of most severe pain	Number of days of most severe pain according to NRS scale	First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Collaborators: Fotona d.o.o.
• Investigators: Principal Investigator: Anna Irga-Staniukiewicz, MD, Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 11, 2020

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (ACTUAL): January 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: low-level laser therapy; hematopoietic stem cell transplantation; oral mucositis; biomodulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: BIOMOD-HSCT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No