NCT07709195 Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant
| NCT ID | NCT07709195 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tata Memorial Centre |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2027-03-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 17 participants in total. It began in 2024-10-30 with a primary completion date of 2027-03-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07709195 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07709195 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07709195 currently recruiting?
Yes, NCT07709195 is actively recruiting participants. Contact the research team at drsumeetmirgh@gmail.com for enrollment information.
Where is the NCT07709195 trial being conducted?
This trial is being conducted at Navi Mumbai, India.
Who is sponsoring the NCT07709195 clinical trial?
NCT07709195 is sponsored by Tata Memorial Centre. The trial plans to enroll 17 participants.