Clinical trial · Interventional
Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs
A Phase II Study to Evaluate Oral Chlorophyllin in Hemorrhagic Cystitis Secondary to Radiation Therapy for Pelvic Malignancies
NCT05348239CI-TRIAL-00058078CLARITYunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemorrhagic Cystitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Copper Chlorophyllin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Chlorophyllin arm
- description
- Participants will receive oral Sodium Copper Chlorophyllin at a dose of 750mg once daily (OD) on an empty stomach.
- interventionNames
- Drug: Sodium Copper Chlorophyllin
Primary outcomes (4)
- measure
- Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
- timeFrame
- Baseline
- description
- Objective Response Rate (ORR) The proportion of patients with CR/PR.The ORR will be determined as below.Complete response(CR):resolution of hematuria (gross/macroscopic hematuria for grade II/III and microscopic hematuria for grade I hemorrhagic cystitis) Partial response(PR):improvement (decrease by at least 1 grade of hemorrhagic cystitis but not complete resolution of hematuria over 3 months from the start of treatment.The grading of hemorrhagic cystitis will be as per the CTCAE v5.0.
- measure
- Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back. * Any grade of radiation-induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3). * Adequate liver function defined as ALT/ALT ≤ 3 times ULN and total bilirubin ≤ 2 times ULN. Elevated transaminases up to 5 times ULN is allowed in patients with liver metastasis. * Adequate renal function defined as creatine clearance ≥ 30 mL/min (By Cockcroft-Gault formula). Exclusion Criteria: * Known hypersensitivity or contraindications against sodium chlorophyllin. * Hemodynamically unstable patients not responding to initial resuscitation. * Patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4).
References
Publications (34)
- BACKGROUNDSmit SG, Heyns CF. Management of radiation cystitis. Nat Rev Urol. 2010 Apr;7(4):206-14. doi: 10.1038/nrurol.2010.23. Epub 2010 Mar 9. PMID 20212517
- BACKGROUNDBrowne C, Davis NF, Mac Craith E, Lennon GM, Mulvin DW, Quinlan DM, Mc Vey GP, Galvin DJ. A Narrative Review on the Pathophysiology and Management for Radiation Cystitis. Adv Urol. 2015;2015:346812. doi: 10.1155/2015/346812. Epub 2015 Dec 22. PMID 26798335
- BACKGROUNDSandhu SS, Goldstraw M, Woodhouse CR. The management of haemorrhagic cystitis with sodium pentosan polysulphate. BJU Int. 2004 Oct;94(6):845-7. doi: 10.1111/j.1464-410X.2004.05044.x. PMID 15476520
- BACKGROUNDFeldmeier JJ, Hampson NB. A systematic review of the literature reporting the application of hyperbaric oxygen prevention and treatment of delayed radiation injuries: an evidence based approach. Undersea Hyperb Med. 2002 Spring;29(1):4-30. PMID 12507182
- BACKGROUNDOscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16. PMID 31537473
- BACKGROUNDVilleirs L, Tailly T, Ost P, Waterloos M, Decaestecker K, Fonteyne V, Van Praet C, Lumen N. Hyperbaric oxygen therapy for radiation cystitis after pelvic radiotherapy: Systematic review of the recent literature. Int J Urol. 2020 Feb;27(2):98-107. doi: 10.1111/iju.14130. Epub 2019 Oct 15. PMID 31617263
- BACKGROUNDLojanapiwat B, Sripralakrit S, Soonthornphan S, Wudhikarn S. Intravesicle formalin instillation with a modified technique for controlling haemorrhage secondary to radiation cystitis. Asian J Surg. 2002 Jul;25(3):232-5. doi: 10.1016/S1015-9584(09)60181-0.