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

Recruiting now · Phase 2

Conditions studied: Oral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)

In brief

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.

Key facts

Study ID

NCT07709195

Run by

Tata Memorial Centre

People needed

17

Starts

2024-10-30

Expected to finish

2027-03-05

Last updated by the study team

2026-07-27

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥12 and ≤65 years of age
• First allogeneic stem cell transplant
• Total body irradiation dose (fractionated) ≥8 Gy

You may not qualify if…

• Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)

Where it is running

• Advanced Centre for Treatment, Research and Education in Cancer — Navi Mumbai, Maharashtra, India (enrolling)

Full record on ClinicalTrials.gov

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