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Urinary Tract Infections Management / Bladder and Urothelial Cancer Treatments / Polyomavirus and Related Diseases · Journal article
Scientific Reports · August 10, 2026
Encouraging direction, but not yet definitive.
This phase II single-arm trial reports a 70.8% objective response rate in 24 patients with radiation-induced chronic haemorrhagic cystitis treated with oral chlorophyllin 750 mg daily for 12 weeks. The drug was well tolerated, produced meaningful improvements in urinary function and quality of life, and showed acceptable safety; however, the absence of a control group limits causal inference and the small sample size requires confirmation in a randomised controlled trial.
Prospective, single-centre, single-arm phase II trial. Adults with chronic haemorrhagic cystitis (grade 2–4 haematuria) persisting ≥3 months after pelvic radiotherapy for cervical (n=15), rectal (n=5), or prostate (n=4) cancer.. Intervention: Oral sodium-copper-chlorophyllin 750 mg daily for 12 weeks. n = 24. Single centre (not specified by name in abstract).
Intention-to-treat ORR was 70.8% (17/24; 95% CI 65%–83%) with 9 complete and 8 partial responses Per-protocol ORR was 80.9% (17/21) Median time to response was 67 days with median response duration of 10 months
Greenish stool discolouration occurred in 79% of patients; nausea in 16%; no discontinuations or severe adverse events
Clinicians should recognise these findings as encouraging preliminary evidence that oral chlorophyllin may offer a non-invasive option for radiation-induced chronic haemorrhagic cystitis with acceptable tolerability. However, the lack of a control group and modest sample size mean these results cannot yet change practice; randomised trials are needed to establish efficacy and durability before wider adoption.
A well-designed single-arm phase II trial with clear efficacy signals (70.8% ORR) and good tolerability, but lacks a control arm and requires randomised confirmation in a larger cohort.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognise these findings as encouraging preliminary evidence that oral chlorophyllin may offer a non-invasive option for radiation-induced chronic haemorrhagic cystitis with acceptable tolerability. However, the lack of a control group and modest sample size mean these results cannot yet change practice; randomised trials are needed to establish efficacy and durability before wider adoption.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Abstract Chronic Haemorrhagic Cystitis (cHC) affects 5–15% of patients after pelvic radiotherapy. Sodium-copper-chlorophyllin, a semi-synthetic chlorophyll derivative, has shown promise in preclinical models. The phase II CLARITY trial evaluated oral chlorophyllin for radiation-induced cHC. This prospective, single-centre, single-arm phase II trial (NCT05348239) enrolled adults with grade 2–4 haematuria persisting ≥ 3 months after pelvic radiotherapy. Participants received chlorophyllin 750 mg orally daily for 12 weeks. The primary endpoint was objective response rate (ORR), including complete (CR) and partial responses (PR). Secondary endpoints were safety, quality of life [Bladder Cancer Index (urinary function, bother) and EORTC QLQ-C30 (global health, summary score)] and exploratory proteomics. Twenty-four patients were enrolled (cervical cancer 15, rectal 5, prostate 4). Baseline haematuria was CTCAE grade 2 in 6 (25%), grade 3 in 17 (71%), and grade 4 in 1 (4%) patient. In the intention-to treat analysis, the ORR was 70.8% (17/24; 95% CI 65%–83%;) with 9 CR and 8 PR, with a median time to response of 67 days and median response duration of 10 months. The per-protocol ORR was 80.9% (17/21). Chlorophyllin was well tolerated with no discontinuations and no severe adverse events. Side effects included greenish discolouration of stools in 79% and nausea in 16% patients. Significant improvements were noted for urinary function and bother and EORTC QLQ-C30 global health and summary scores. Proteomics suggested modulation of complement, coagulation, inflammatory, oxidative stress, and repair pathways. Oral chlorophyllin showed encouraging response in radiotherapy-related haemorrhagic cystitis with favourable tolerability and quality of life gains. These findings support randomised trials to confirm efficacy and durability.
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