Chlorophyllin to reduce mouth sores before allogeneic stem cell transplant
Official title: Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation
Run by Tata Memorial Centre · NCT07709195 · Data updated 2026-11-12
This phase II study tests whether taking chlorophyllin by mouth can lower the chances and severity of mouth ulcers in patients aged 12–65 undergoing radiation-based conditioning before a first allogeneic stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Enrollment | 17 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Navi Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | October 30, 2024 |
| Main results expected | March 5, 2027 |
| Study ends | March 5, 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07709195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 12–65 undergoing first allogeneic HSCT with planned fractionated TBI ≥8 Gy and no known hypersensitivity to chlorophyllin.
✕Probably not a fit
Patients with contraindications to chlorophyllin or those not receiving TBI-based conditioning may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm Phase II trial evaluating oral sodium copper chlorophyllin as a preventive measure against radiation-induced oral mucositis in patients receiving myeloablative total body irradiation prior to their first allogeneic HSCT. Participants will start 750 mg daily 48 hours before conditioning and continue through day +28 after transplant. The study focuses on whether chlorophyllin can reduce the incidence of Grade III/IV mucositis, shorten its duration, and lessen related supportive-care needs while maintaining safety. Outcomes include rates of severe mucositis, duration, nutrition support requirements, analgesic use, and treatment-related toxicities. The trial addresses the lack of widely available prophylaxis for radiation-induced mucositis in this setting.
Why it matters
Potential benefit: If successful, chlorophyllin could meaningfully reduce mouth ulcers and related complications, improving comfort and recovery after transplant.
How similar studies have gone: Prior research supports chlorophyllin's protective and anti-inflammatory properties, but evidence in radiation-induced mucositis for HSCT is limited and this trial explores a novel application in TBI contexts.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, Maharashtra, India Recruiting
Study contacts
- Study coordinator: Sumeet Mirgh, MBBS MD DM Clinical Hematology
- Email: drsumeetmirgh@gmail.com
- Phone: +91 9769918905
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.