An interventional study of Laser therapy in Oral Mucositis and Bone Marrow Transplant Complications, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Prevention
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.
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 are observed and receive standard supportive care.
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.
Duration of oral mucositis
Duration of oral mucositis duration in days measured in both groups
Time frame: 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
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Need for opioid analgesics calculated
Opioid analgesic need assessed in days
Time frame: 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
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Gdansk