This clinical trial evaluates intraoral photobiomodulation therapy (PBMT) for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (HCT). Allogeneic HCT is a potentially curative therapy for a variety of cancerous and non-cancerous diseases, but the drugs given both prior to the transplant (myeloablative conditioning) as well as after the transplant can cause treatment-related side effects such as oral mucositis. Oral mucositis is a common, painful, and debilitating condition characterized by mucosal ulceration resulting in severe mouth and throat pain, leading to the inability to eat and drink, reduction in quality of life, extended hospital stay, and an overall increase in the cost of care. PBMT uses red or near infrared light to stimulate tissue repair and restoration after injury or inflammation and may prevent or reduce oral mucositis symptoms in patients undergoing an allogeneic HCT after a period of conditioning.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05335434.
PRIMARY OBJECTIVE:
I. To describe the effect of intraoral PBMT, when applied once daily from initiation of conditioning until 20 days following stem cell infusion (day +20) in adults undergoing myeloablative allogeneic HCT, on the duration of severe (grades 3 or 4, according to the World Health Organization [WHO]) oral mucositis.
SECONDARY OBJECTIVES:
I. To describe the severity of mucositis according to mouth pain categorical rating scale and Oral Mucositis Daily Questionnaire (OMDQ) in patients treated with intraoral PBMT.
II. To describe the adverse events potentially related to intraoral PBMT.
III. To describe the duration of time to complete PBMT administration.
IV. To describe the need for nutritional support by measuring hypocaloric intake < 50% of needs x 5 days per calorie counts in patients treated with intraoral PBMT.
V. To describe the need for total parenteral nutrition (TPN) initiation in patients treated with intraoral PBMT.
VI. To describe the operator and patient acceptability of treatment with intraoral PBMT.
OUTLINE:
Patients undergo intraoral PBMT with the THOR LX2.3 light-emitting diode (LED) Lollipop device for 2 minutes once daily (QD) beginning on the first day of standard of care conditioning and continuing until 20 days after standard of care allogeneic HCT.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorKentaro Ikeda
