Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant (ChROMME-TBI)
23. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Status
Rekrutierung
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Studientyp
Interventionell
Einschreibung (Geschätzt)
Einschreibung
17
Phase
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
Studienkontakt
- Name: Sumeet Mirgh, MBBS MD DM Clinical Hematology
- Telefonnummer: +91 9769918905
- E-Mail: drsumeetmirgh@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Dr. Anant Gokarn, MBBS MD DM Medical Oncology
- Telefonnummer: +91 8097295540
- E-Mail: anantgokarn@gmail.com
Studienorte
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Maharashtra
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Navi Mumbai, Maharashtra, Indien, 410210
- Rekrutierung
- Advanced Centre for Treatment, Research and Education in Cancer
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Kontakt:
- Sumeet Mirgh, MBBS MD DM clinical hematology
- Telefonnummer: 8679/8696 +91 8130140245
- E-Mail: drsumeetmirgh@gmail.com
-
Kontakt:
- Anant Gokarn, MBBS DM MD Medical Oncology
- E-Mail: anantgokarn@gmail.com
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
1
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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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.
|
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Grade III-IV Oral Mucositis
Zeitfenster: From initiation of conditioning until Day +28 after HSCT.
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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).
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From initiation of conditioning until Day +28 after HSCT.
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Total Parenteral Nutrition (TPN) Use
Zeitfenster: Day 0 to Day +28 after HSCT
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Proportion of participants requiring total parenteral nutrition during the study period.
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Day 0 to Day +28 after HSCT
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Duration of Total Parenteral Nutrition (TPN)
Zeitfenster: Day 0 to Day +28 after HSCT
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Duration of total parenteral nutrition use, measured as the number of days participants require TPN.
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Day 0 to Day +28 after HSCT
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Incidence of Opioid Analgesic Use
Zeitfenster: Day 0 to Day +28 after HSCT
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Proportion of participants requiring opioid analgesics for pain management.
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Day 0 to Day +28 after HSCT
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Duration of Opioid Analgesic Use
Zeitfenster: Day 0 to Day +28 after HSCT
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Number of days participants receive opioid analgesics
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Day 0 to Day +28 after HSCT
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Time to Neutrophil and Platelet Engraftment
Zeitfenster: Up to Day +28 after HSCT
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Time from transplantation to neutrophil and platelet engraftment, measured in days.
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Up to Day +28 after HSCT
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Incidence of Grade III-IV Diarrhea
Zeitfenster: Day 0 to Day +28 after HSCT
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Incidence of Grade III-IV diarrhea assessed according to CTCAE Version 5.0.
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Day 0 to Day +28 after HSCT
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Non-Relapse Mortality (NRM)
Zeitfenster: 100 days after allogeneic HSCT
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Death from any cause other than disease relapse or refractory disease.
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100 days after allogeneic HSCT
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Cumulative Incidence of Grade III-IV Acute Graft-versus-Host Disease (GVHD)
Zeitfenster: 100 days after allogeneic HSCT
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Cumulative incidence of Grade III-IV acute GVHD assessed using the Glucksberg grading system
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100 days after allogeneic HSCT
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Duration of Grade III-IV Oral Mucositis
Zeitfenster: Day 0 to Day +28 after HSCT
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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 (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)
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Day 0 to Day +28 after HSCT
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- Raber-Durlacher JE, von Bultzingslowen I, Logan RM, Bowen J, Al-Azri AR, Everaus H, Gerber E, Gomez JG, Pettersson BG, Soga Y, Spijkervet FK, Tissing WJ, Epstein JB, Elad S, Lalla RV; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients. Support Care Cancer. 2013 Jan;21(1):343-55. doi: 10.1007/s00520-012-1594-5. Epub 2012 Sep 18.
- Logan RM, Stringer AM, Bowen JM, Yeoh AS, Gibson RJ, Sonis ST, Keefe DM. The role of pro-inflammatory cytokines in cancer treatment-induced alimentary tract mucositis: pathobiology, animal models and cytotoxic drugs. Cancer Treat Rev. 2007 Aug;33(5):448-60. doi: 10.1016/j.ctrv.2007.03.001. Epub 2007 May 15.
- CTRI clinical trial data of phase 1 study of chlorophyllin in healthy subjects - CTRI/2018/09/015576
- Kumar Gupta S, Gohil D, Dutta D, Panigrahi GC, Gupta P, Dalvi K, Khanka T, Yadav S, Kumar Kaushal R, Chichra A, Punatar S, Gokarn A, Mirgh S, Jindal N, Nayak L, Tembhare PR, Khizer Hasan S, Kumar Sandur S, Hingorani L, Khattry N, Gota V. Withaferin-A alleviates acute graft versus host disease without compromising graft versus leukemia effect. Int Immunopharmacol. 2023 Aug;121:110437. doi: 10.1016/j.intimp.2023.110437. Epub 2023 Jun 11.
- Suryavanshi S, Sharma D, Checker R, Thoh M, Gota V, Sandur SK, Sainis KB. Amelioration of radiation-induced hematopoietic syndrome by an antioxidant chlorophyllin through increased stem cell activity and modulation of hematopoiesis. Free Radic Biol Med. 2015 Aug;85:56-70. doi: 10.1016/j.freeradbiomed.2015.04.007. Epub 2015 Apr 11.
- Sharma D, Kumar SS, Sainis KB. Antiapoptotic and immunomodulatory effects of chlorophyllin. Mol Immunol. 2007 Jan;44(4):347-59. doi: 10.1016/j.molimm.2006.02.031. Epub 2006 Apr 17.
- Kumar SS, Shankar B, Sainis KB. Effect of chlorophyllin against oxidative stress in splenic lymphocytes in vitro and in vivo. Biochim Biophys Acta. 2004 May 3;1672(2):100-11. doi: 10.1016/j.bbagen.2004.03.002.
- US Patent. Chlorophyllin drug insert
- Brizel DM, Wasserman TH, Henke M, Strnad V, Rudat V, Monnier A, Eschwege F, Zhang J, Russell L, Oster W, Sauer R. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000 Oct 1;18(19):3339-45. doi: 10.1200/JCO.2000.18.19.3339.
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- Langner S, Staber P, Schub N, Gramatzki M, Grothe W, Behre G, Rabitsch W, Urban C, Linkesch W, Neumeister P. Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients. Bone Marrow Transplant. 2008 Aug;42(4):275-9. doi: 10.1038/bmt.2008.157. Epub 2008 May 26.
- Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
- Giralt S, Ballen K, Rizzo D, Bacigalupo A, Horowitz M, Pasquini M, Sandmaier B. Reduced-intensity conditioning regimen workshop: defining the dose spectrum. Report of a workshop convened by the center for international blood and marrow transplant research. Biol Blood Marrow Transplant. 2009 Mar;15(3):367-9. doi: 10.1016/j.bbmt.2008.12.497.
- Gupta T, Kannan S, Dantkale V, Laskar S. Cyclophosphamide plus total body irradiation compared with busulfan plus cyclophosphamide as a conditioning regimen prior to hematopoietic stem cell transplantation in patients with leukemia: a systematic review and meta-analysis. Hematol Oncol Stem Cell Ther. 2011;4(1):17-29. doi: 10.5144/1658-3876.2011.17.
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- Wolden SL, Rabinovitch RA, Bittner NH, Galvin JM, Giap HB, Schomberg PJ, Rosenthal SA; American College of Radiology; American Society for Radiation Oncology. American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) practice guideline for the performance of total body irradiation (TBI). Am J Clin Oncol. 2013 Feb;36(1):97-101. doi: 10.1097/COC.0b013e31826e0528.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
30. Oktober 2024
Primärer Abschluss (Geschätzt)
Primärer Abschluss
5. März 2027
Studienabschluss (Geschätzt)
Studienabschluss
5. März 2027
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
11. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Juli 2026
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
16. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
27. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Juli 2026
Zuletzt verifiziert
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 901010
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Beschreibung des IPD-Plans
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.
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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