Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant (ChROMME-TBI)
23. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
17
Fáze
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Sumeet Mirgh, MBBS MD DM Clinical Hematology
- Telefonní číslo: +91 9769918905
- E-mail: drsumeetmirgh@gmail.com
Studijní záloha kontaktů
- Jméno: Dr. Anant Gokarn, MBBS MD DM Medical Oncology
- Telefonní číslo: +91 8097295540
- E-mail: anantgokarn@gmail.com
Studijní místa
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Maharashtra
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Navi Mumbai, Maharashtra, Indie, 410210
- Nábor
- Advanced Centre for Treatment, Research and Education in Cancer
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Kontakt:
- Sumeet Mirgh, MBBS MD DM clinical hematology
- Telefonní číslo: 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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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Počet zbraní
1
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Grade III-IV Oral Mucositis
Časové okno: 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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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Total Parenteral Nutrition (TPN) Use
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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 (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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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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.
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- Nakagaki M, Kennedy GA, Gavin NC, Clavarino A, Whitfield K. The incidence of severe oral mucositis in patients undergoing different conditioning regimens in haematopoietic stem cell transplantation. Support Care Cancer. 2022 Nov;30(11):9141-9149. doi: 10.1007/s00520-022-07328-4. Epub 2022 Aug 26.
- 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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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
30. října 2024
Primární dokončení (Odhadovaný)
Primární dokončení
5. března 2027
Dokončení studie (Odhadovaný)
Dokončení studie
5. března 2027
Termíny zápisu do studia
První předloženo
První předloženo
11. července 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
11. července 2026
První zveřejněno (Aktuální)
První zveřejněno
16. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
27. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. července 2026
Naposledy ověřeno
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 901010
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .