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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175222
• Other study ID #: BIOMOD-HSCT1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 11, 2020

Study information

• Verified date: December 2021
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 11, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Transplant Complications
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk	Pomeranian

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Gdansk	Fotona d.o.o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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