Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant (ChROMME-TBI)

July 17, 2026 updated by: Dr Sumeet Mirgh, Tata Memorial Centre

Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Total body irradiation (TBI)-based myeloablative conditioning is an established component of allogeneic hematopoietic stem cell transplantation (HSCT) for patients with Hematologic Malignancies, particularly acute leukemias. Although effective, TBI is associated with significant acute toxicities, among which oral mucositis is one of the most common and debilitating complications. Severe (Grade III-IV) oral mucositis can result in severe pain, inability to eat, increased opioid analgesic use, total parenteral nutrition (TPN), prolonged hospitalization, and increased risk of infection. Published studies have reported a 44-71% incidence of severe oral mucositis following TBI-based conditioning, while institutional data demonstrate an incidence of approximately 70%.

Currently, there is no widely available standard prophylactic therapy for preventing radiation-induced oral mucositis in patients undergoing TBI-based conditioning. Palifermin has shown benefit in selected transplant populations but has limited evidence in TBI recipients, is costly, and is not readily available in India. Therefore, there is a need for a safe, affordable, and effective preventive strategy.

Sodium copper chlorophyllin (CHL) is a phytopharmaceutical derived from chlorophyll with antioxidant, anti-inflammatory, immunomodulatory, and radioprotective properties. Preclinical studies have demonstrated that CHL scavenges radiation-induced free radicals, reduces radiation-related tissue injury, promotes hematopoietic recovery, and protects normal tissues without protecting malignant cells or compromising the graft-versus-leukemia effect. A completed Phase I clinical study in healthy volunteers demonstrated that oral CHL is safe and well tolerated.

This prospective, single-center, single-arm Phase II study will evaluate the efficacy and safety of oral CHL in reducing severe oral mucositis in patients undergoing myeloablative TBI prior to first allogeneic HSCT. Eligible participants aged 12-65 years will receive oral CHL 750 mg once daily (tablet or oral suspension) beginning 48 hours before initiation of TBI conditioning and continuing until day +28 after transplantation, in addition to standard conditioning and transplant care.

The primary endpoint is the incidence of Grade III-IV oral mucositis by day +28 following HSCT. Secondary endpoints include the duration of severe oral mucositis, incidence and duration of TPN and opioid analgesic use, incidence of Grade III-IV nausea, vomiting and diarrhea, time to neutrophil and platelet engraftment, cumulative incidence of acute graft-versus-host disease (GVHD) by day 100, and non-relapse mortality. Exploratory objectives include evaluation of inflammatory cytokine profiles and the pharmacokinetic profile of CHL.

The findings from this study will provide preliminary evidence regarding the effectiveness of chlorophyllin as an inexpensive and well-tolerated radioprotective agent for reducing oral mucositis in patients undergoing TBI-based conditioning for allogeneic HSCT and will inform the design of future randomized clinical trials.

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr. Anant Gokarn, MBBS MD DM Medical Oncology
  • Phone Number: +91 8097295540
  • Email: anantgokarn@gmail.com

Study Locations

  • India
    • Maharashtra
      • Navi Mumbai, Maharashtra, India, 410210
        • Recruiting
        • Advanced Centre for Treatment, Research and Education in Cancer
        • Contact:
          • Sumeet Mirgh, MBBS MD DM clinical hematology
          • Phone Number: 8679/8696 +91 8130140245
          • Email: drsumeetmirgh@gmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Sodium Copper Chlorophyllin
Participants will receive oral sodium copper chlorophyllin (CHL) 750 mg once daily (tablet or oral suspension) beginning 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning (Day -9) and continuing until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). All participants will receive standard TBI-based conditioning and HSCT as part of routine clinical care. The study will evaluate the efficacy and safety of CHL in reducing the incidence and severity of oral mucositis.
Drug: Sodium Copper Chlorophyllin
Sodium copper chlorophyllin (CHL) will be administered orally at a dose of 750 mg once daily (tablet or oral suspension) on an empty stomach, starting 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning and continued until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). The study drug is administered as an adjunct to standard TBI-based conditioning to evaluate its efficacy in reducing the incidence and severity of oral mucositis.
Other Names:
  • CHL
  • Chlorophyllin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade III-IV Oral Mucositis
Time Frame: From initiation of conditioning until Day +28 after HSCT.
The incidence of Grade III-IV oral mucositis will be assessed using the WHO Oral Mucositis Grading Scale in participants receiving oral sodium copper chlorophyllin during myeloablative total body irradiation (TBI)-based conditioning prior to allogeneic hematopoietic stem cell transplantation (HSCT).
From initiation of conditioning until Day +28 after HSCT.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Total Parenteral Nutrition (TPN) Use
Time Frame: Day 0 to Day +28 after HSCT
Proportion of participants requiring total parenteral nutrition during the study period.
Day 0 to Day +28 after HSCT
Duration of Total Parenteral Nutrition (TPN)
Time Frame: Day 0 to Day +28 after HSCT
Duration of total parenteral nutrition use, measured as the number of days participants require TPN.
Day 0 to Day +28 after HSCT
Incidence of Opioid Analgesic Use
Time Frame: Day 0 to Day +28 after HSCT
Proportion of participants requiring opioid analgesics for pain management.
Day 0 to Day +28 after HSCT
Duration of Opioid Analgesic Use
Time Frame: Day 0 to Day +28 after HSCT
Number of days participants receive opioid analgesics
Day 0 to Day +28 after HSCT
Time to Neutrophil and Platelet Engraftment
Time Frame: Up to Day +28 after HSCT
Time from transplantation to neutrophil and platelet engraftment, measured in days.
Up to Day +28 after HSCT
Incidence of Grade III-IV Diarrhea
Time Frame: Day 0 to Day +28 after HSCT
Incidence of Grade III-IV diarrhea assessed according to CTCAE Version 5.0.
Day 0 to Day +28 after HSCT
Non-Relapse Mortality (NRM)
Time Frame: 100 days after allogeneic HSCT
Death from any cause other than disease relapse or refractory disease.
100 days after allogeneic HSCT
Cumulative Incidence of Grade III-IV Acute Graft-versus-Host Disease (GVHD)
Time Frame: 100 days after allogeneic HSCT
Cumulative incidence of Grade III-IV acute GVHD assessed using the Glucksberg grading system
100 days after allogeneic HSCT
Duration of Grade III-IV Oral Mucositis
Time Frame: Day 0 to Day +28 after HSCT
Duration of Grade III-IV oral mucositis, measured as the number of days participants experience severe oral mucositis based on the WHO Oral Mucositis Grading Scale.
Day 0 to Day +28 after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

March 5, 2027

Study Completion (Estimated)

March 5, 2027

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 901010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant confidentiality and privacy will be protected in accordance with institutional policies, applicable regulations, and informed consent. Only de-identified aggregate study results will be reported in scientific publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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