Oral MucositisPhase 2ChROMME-TBINCT07709195
Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant
A Phase 2 study testing Sodium Copper Chlorophyllin in people with Oral Mucositis and Total Body Irradiation, run by Tata Memorial Centre at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Oral Mucositis, Total Body Irradiation, Hematological Malignancies
- What is being tested?
- Sodium Copper Chlorophyllin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2024to 5 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥12 and ≤65 years of age
- First allogeneic stem cell transplant
- Total body irradiation dose (fractionated) ≥8 Gy
Who cannot join
- Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, Maharashtra, 410210
Sumeet Mirgh, MBBS MD DM clinical hematology, +91 8130140245 ext. 8679/8696, drsumeetmirgh@gmail.com
Anant Gokarn, MBBS DM MD Medical Oncology, anantgokarn@gmail.com
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Oral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)
- Being tested
- Sodium Copper Chlorophyllin
- Keywords
- Chlorophyllin, Oral Mucositis, Allogeneic HSCT, Phase II Trial, Supportive Care, Acute Leukemia, Total Body Irradiation
- Medical subject headings
- Stomatitis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Copper ChlorophyllinDrug
Also called CHL, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium Copper Chlorophyllin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From initiation of conditioning until Day +28 after HSCT.
Secondary outcomes (9)
Duration of Grade III-IV Oral Mucositis
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)
Measured: Day 0 to Day +28 after HSCT
Incidence of Total Parenteral Nutrition (TPN) Use
Proportion of participants requiring total parenteral nutrition during the study period.
Measured: Day 0 to Day +28 after HSCT
Duration of Total Parenteral Nutrition (TPN)
Duration of total parenteral nutrition use, measured as the number of days participants require TPN.
Measured: Day 0 to Day +28 after HSCT
Incidence of Opioid Analgesic Use
Proportion of participants requiring opioid analgesics for pain management.
Measured: Day 0 to Day +28 after HSCT
Duration of Opioid Analgesic Use
Number of days participants receive opioid analgesics
Measured: Day 0 to Day +28 after HSCT
Time to Neutrophil and Platelet Engraftment
Time from transplantation to neutrophil and platelet engraftment, measured in days.
Measured: Up to Day +28 after HSCT
Incidence of Grade III-IV Diarrhea
Incidence of Grade III-IV diarrhea assessed according to CTCAE Version 5.0.
Measured: Day 0 to Day +28 after HSCT
Non-Relapse Mortality (NRM)
Death from any cause other than disease relapse or refractory disease.
Measured: 100 days after allogeneic HSCT
Cumulative Incidence of Grade III-IV Acute Graft-versus-Host Disease (GVHD)
Cumulative incidence of Grade III-IV acute GVHD assessed using the Glucksberg grading system
Measured: 100 days after allogeneic HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start30 Oct 2024
- Primary completion5 Mar 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sumeet Mirgh, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709195
- Sponsor's protocol ID
- 901010
- Acronym
- ChROMME-TBI
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Punatar S, Katti K, Rajamanickam D, Patil P, Dhakan C, Bagal B, Gokarn A, Bonda A, Nayak L, Gurjar M, Kannan S, Chiplunkar S, Gota V, Khattry N. Role of Curcumin in Reducing Toxicities Associated With Mucosal Injury Following Melphalan-Based Conditioning in Autologous Transplant Setting. Cell Transplant. 2022 Jan-Dec;31:9636897221086969. doi: 10.1177/09636897221086969.
PubMed 35435039Raber-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.
PubMed 22987094Logan 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.
PubMed 17507164CTRI 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.
PubMed 37311352Suryavanshi 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.
PubMed 25872101Sharma 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.
PubMed 16616780Kumar 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.
PubMed 15110092US 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.
PubMed 11013273Rades D, Fehlauer F, Bajrovic A, Mahlmann B, Richter E, Alberti W. Serious adverse effects of amifostine during radiotherapy in head and neck cancer patients. Radiother Oncol. 2004 Mar;70(3):261-4. doi: 10.1016/j.radonc.2003.10.005.
PubMed 15064010King M, Joseph S, Albert A, Thomas TV, Nittala MR, Woods WC, Vijayakumar S, Packianathan S. Use of Amifostine for Cytoprotection during Radiation Therapy: A Review. Oncology. 2020;98(2):61-80. doi: 10.1159/000502979. Epub 2019 Dec 17.
PubMed 31846959Hadid T, Al-Katib A, Binongo J, Berteotti GM, Fazal S, Rossetti JM, Lister J. Palifermin Compared to Supersaturated Calcium Phosphate Rinse in Prevention of Severe Oral Mucositis after Stem Cell Transplantation in Patients Receiving Radiotherapy-Based Myeloablative Conditioning. Hemato. 2023; 4(1):58-67. https://doi.org/10.3390/hemato4010006
Papas AS, Clark RE, Martuscelli G, O'Loughlin KT, Johansen E, Miller KB. A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2003 Apr;31(8):705-12. doi: 10.1038/sj.bmt.1703870.
PubMed 12692611Spielberger R, Stiff P, Bensinger W, Gentile T, Weisdorf D, Kewalramani T, Shea T, Yanovich S, Hansen K, Noga S, McCarty J, LeMaistre CF, Sung EC, Blazar BR, Elhardt D, Chen MG, Emmanouilides C. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med. 2004 Dec 16;351(25):2590-8. doi: 10.1056/NEJMoa040125.
PubMed 15602019
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation
- ClinicalTrials.gov ID
- NCT07709195
- Acronym / sponsor ID
- ChROMME-TBI / 901010
- Conditions
- Oral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)
- Keywords
- Chlorophyllin, Oral Mucositis, Allogeneic HSCT, Phase II Trial, Supportive Care, Acute Leukemia, Total Body Irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Sodium Copper Chlorophyllin | Experimental | Drug: Sodium Copper ChlorophyllinParticipants 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥12 and ≤65 years of age
- First allogeneic stem cell transplant
- Total body irradiation dose (fractionated) ≥8 Gy
Key exclusion criteria (1 listed)
- Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Copper ChlorophyllinAlso: CHL, ChlorophyllinSodium 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. | Drug | Oral Sodium Copper Chlorophyllin |
Primary outcome
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 (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).
9 secondary outcomes
Duration of Grade III-IV Oral Mucositis
Time frame: Day 0 to Day +28 after HSCT
Incidence of Total Parenteral Nutrition (TPN) Use
Time frame: Day 0 to Day +28 after HSCT
Duration of Total Parenteral Nutrition (TPN)
Time frame: Day 0 to Day +28 after HSCT
Incidence of Opioid Analgesic Use
Time frame: Day 0 to Day +28 after HSCT
Duration of Opioid Analgesic Use
Time frame: Day 0 to Day +28 after HSCT
Time to Neutrophil and Platelet Engraftment
Time frame: Up to Day +28 after HSCT
Incidence of Grade III-IV Diarrhea
Time frame: Day 0 to Day +28 after HSCT
Non-Relapse Mortality (NRM)
Time frame: 100 days after allogeneic HSCT
Cumulative Incidence of Grade III-IV Acute Graft-versus-Host Disease (GVHD)
Time frame: 100 days after allogeneic HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Results publication: PubMed 35435039Punatar S, Katti K, Rajamanickam D, Patil P, Dhakan C, Bagal B, Gokarn A, Bonda A, Nayak L, Gurjar M, Kannan S, Chiplunkar S, Gota V, Khattry N. Role of Curcumin in Reducing Toxicities Associated With Mucosal Injury Following Melphalan-Based Conditioning in Autologous Transplant Setting. Cell Transplant. 2022 Jan-Dec;31:9636897221086969. doi: 10.1177/09636897221086969.
- Results publication: PubMed 22987094Raber-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.
- Results publication: PubMed 17507164Logan 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.
- Results publicationCTRI clinical trial data of phase 1 study of chlorophyllin in healthy subjects - CTRI/2018/09/015576
- Results publication: PubMed 37311352Kumar 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.
- Results publication: PubMed 25872101Suryavanshi 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.
- Results publication: PubMed 16616780Sharma 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.
- Results publication: PubMed 15110092Kumar 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.
- Results publicationUS Patent. Chlorophyllin drug insert
- Results publication: PubMed 11013273Brizel 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.
- Results publication: PubMed 15064010Rades D, Fehlauer F, Bajrovic A, Mahlmann B, Richter E, Alberti W. Serious adverse effects of amifostine during radiotherapy in head and neck cancer patients. Radiother Oncol. 2004 Mar;70(3):261-4. doi: 10.1016/j.radonc.2003.10.005.
- Results publication: PubMed 31846959King M, Joseph S, Albert A, Thomas TV, Nittala MR, Woods WC, Vijayakumar S, Packianathan S. Use of Amifostine for Cytoprotection during Radiation Therapy: A Review. Oncology. 2020;98(2):61-80. doi: 10.1159/000502979. Epub 2019 Dec 17.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Copper Chlorophyllin in people with Oral Mucositis and Total Body Irradiation, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumeet Mirgh, MBBS MD DM Clinical Hematology (+91 9769918905, drsumeetmirgh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade III-IV Oral Mucositis (time frame: From initiation of conditioning until Day +28 after HSCT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07709195, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.