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NCT07709195
Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant
Conditions: Oral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)
Sex: All
Ages: 12 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 17
Sponsor: Tata Memorial Centre
Location: Advanced Centre for Treatment, Research and Education in Cancer Navi Mumbai Maharashtra
Summary
The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
The main questions it aims to answer are:
Does oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety?
Participants will:
Receive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT.
Undergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care.
Have regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD).
Provide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.
Eligibility Criteria
Inclusion Criteria
* Patients ≥12 and ≤65 years of age
* First allogeneic stem cell transplant
* Total body irradiation dose (fractionated) ≥8 Gy
Exclusion Criteria
* Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)
Source: ClinicalTrials.gov (NCT07709195). StuddyBuddy aggregates publicly available trial information.