Oral Sodium Copper Chlorophyllin to Reduce Severe Oral Mucositis in Patients Receiving Myeloablative Total Body Irradiation Before First Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are evaluating oral sodium copper chlorophyllin CHL in patients aged 12 to 65 years who are undergoing myeloablative total body irradiation TBI as part of conditioning before their first allogeneic hematopoietic stem cell transplantation HSCT. This Phase II, single-arm study aims to assess whether CHL can reduce the frequency and severity of oral mucositis, a common and painful complication of TBI that affects eating, increases pain medication use, and can lead to longer hospital stays and infections. Participants will receive 750 mg of oral sodium copper chlorophyllin once daily, either as a tablet or oral suspension, starting 48 hours before beginning TBI conditioning and continuing until 28 days after the transplant. Alongside this, they will undergo standard TBI-based conditioning and allogeneic HSCT as part of their routine medical care. The study focuses on the safety and effectiveness of CHL in reducing severe oral mucositis and related treatment toxicities. During the study, participants will have regular clinical assessments to monitor oral mucositis severity, treatment-related side effects, engraftment progress, and graft-versus-host disease. Blood and saliva samples will be collected at set times for analysis of inflammatory markers and drug levels. The primary measure is the occurrence of severe oral mucositis by 28 days post-transplant, with additional outcomes including duration of mucositis, use of nutrition and pain medications, and transplant complications. The total study period extends through 100 days post-transplant for some assessments.

Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant