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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Gdansk
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Duration of oral mucositis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Duration of oral mucositis
Time Frame: 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
Time Frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Evaluation of pain according to NRS scale
Secondary Outcomes
- 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)