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

Not Applicable

Completed

• Conditions: Bone Marrow Transplant Complications; Oral Mucositis
• Interventions: Radiation: Laser therapy

• Registration Number: NCT05175222
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-11
• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-03
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Gdańsk; 🇵🇱 Gdańsk, Pomeranian, Poland