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

Study acronym: ChROMME-TBI
StatusRecruiting
PhasePhase 2
Started2024-10-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Tata Memorial Centre

Amendment history

2026-07-23
Study Status, Outcome Measures v2
Secondary endpointsdetails revised at 1 of 9 entries
2026-07-17
Study Identification, Study Status, Study Description, Conditions, Outcome Measures, Eligibility v1
Primary endpoint(s) modified1 entry, revised
WasIncidence of Grade III and IV Oral Mucositis
NowIncidence of Grade III-IV Oral Mucositis
Eligibility criteria+1 characters
Inclusion Criteria Patients ≥12- and ≤65 years of age First allogeneic stem cell transplant Total body irradiation dose (fractionated) ≥8Gy8 Gy Exclusion Criteria Known hypersensitivity or contraindications againstto sodium chlorophyllin (CHL)
Secondary endpoints9 entries, revised
Duration of Grade III and -IV Oral Mucositis
Study description-2 characters
[...] opoietic stem cell transplantation (HSCT) for patients with hematologicalHematologic malignanciesMalignancies, particularly acute leukemias. Although effective, TBI is a [...] ulative incidence of acute graft-versus-host disease (GVHD) atby day 100, and non-relapse mortality. Exploratory objectives [...]
2026-07-11
Original filing
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.
Trial Details
NCT Number NCT07709195
Lead Sponsor Tata Memorial Centre
Conditions Oral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)
Enrollment 17 participants
Start Date 2024-10-30
Primary Completion 2027-03-05 (estimated)
Study Completion 2027-03-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-27