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

NCT05175222 | Completed

• 1 other identifier: BIOMOD-HSCT1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis; Bone Marrow Transplant Complications

Keywords

oral mucositis; low-level laser therapy; biomodulation; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Need for opioid analgesics calculated

  First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation

• Length of most severe pain

  First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation

Study Arms (2)

Laser

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients are observed and receive standard supportive care.

Interventions

Laser therapy RADIATION

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.

Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Fotona d.o.o.: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Pomeranian, 80-210, Poland

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Anna Irga-Staniukiewicz, MD

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 11, 2020
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

PL (1)