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

NCT07709195 | Recruiting Phase 2 DMC

• 1 other identifier: 901010
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancies; Oral Mucositis; Total Body Irradiation; Hematopoietic Stem Cell Transplantation (HSCT)

Keywords

Chlorophyllin; Oral Mucositis; Allogeneic HSCT; Phase II Trial; Supportive Care; Acute Leukemia; Total Body Irradiation

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade III-IV Oral Mucositis

  The incidence of Grade III-IV oral mucositis will be assessed using the WHO Oral Mucositis Grading Scale (Grade 0: No oral mucositis.Grade 1: Erythema (redness) and soreness.Grade 2: Ulcers are present, but the patient is still able to tolerate solid foods.Grade 3: Extensive ulcers requiring the patient to switch to a liquid diet.Grade 4: Severe ulceration, making all oral alimentation (eating and drinking) impossible) 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 Outcomes (9)

• Duration of Grade III-IV Oral Mucositis

  Day 0 to Day +28 after HSCT

• Incidence of Total Parenteral Nutrition (TPN) Use

  Day 0 to Day +28 after HSCT

• Duration of Total Parenteral Nutrition (TPN)

  Day 0 to Day +28 after HSCT

• Incidence of Opioid Analgesic Use

  Day 0 to Day +28 after HSCT

• Duration of Opioid Analgesic Use

  Day 0 to Day +28 after HSCT

Study Arms (1)

Oral Sodium Copper Chlorophyllin

EXPERIMENTAL

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

Interventions

Sodium Copper Chlorophyllin DRUG

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.

Also known as: CHL, Chlorophyllin

Oral Sodium Copper Chlorophyllin

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Stomatitis; Hematologic Neoplasms

Interventions

chlorophyllin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Sumeet Mirgh, MBBS MD DM Clinical Hematology

CONTACT

+91 9769918905; drsumeetmirgh@gmail.com

Dr. Anant Gokarn, MBBS MD DM Medical Oncology

CONTACT

+91 8097295540; anantgokarn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, single-center, single-arm, interventional Phase II study. All enrolled participants receive the same intervention (oral chlorophyllin) with no randomization and no comparison arm.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: October 30, 2024
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)