Hemorrhagic CystitisPhase 2CLARITYNCT05348239
Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs
A Phase 2 study testing Sodium Copper Chlorophyllin in people with Hemorrhagic Cystitis, run by Tata Memorial Centre at 1 site in India.
Trial summary
To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Cystitis
- 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
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 26 Mar 2022to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Dr. Gagan Prakash, 022 2417 ext. 7176, gagan2311@gmail.com
Dr. Vikram Gota, +91 7715019117, vikramgota@gmail.com
About this study
Official title: A Phase II Study to Evaluate Oral Chlorophyllin in Hemorrhagic Cystitis Secondary to Radiation Therapy for Pelvic Malignancies
To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.
Read the detailed description
Radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. Intensity modulation and image guidance have improved the delivery of radiation therapy in recent times. However, this does not eliminate the risk of radiation-induced damage to the adjacent healthy tissue - in this consideration, the bladder. Hemorrhagic cystitis accounts for 5-7% of emergency urology admissions. The procedure for the management of radiation cystitis proceeds from non-invasive oral drugs and HBOT to minimally invasive treatment like intravesical therapy and angioembolization, to more morbid procedures like cystectomy and urinary diversion. Although these treatment modalities have shown some success, most patients continue to have recurrent/persistent hematuria. There is a need to explore options of other oral/intravesical agents which can aid in mucosal healing and stop hematuria with lasting effects. Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. Research at BARC has shown that chlorophyllin prevents radiation-induced toxicity in normal hematopoietic tissues and normal epithelial cells. A phase 1 clinical study in healthy volunteers indicate that CHL is safe and tolerable in humans and has not shown any severe adverse events. The purpose of this study is to evaluate the safety and efficacy of oral sodium copper chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancy.
- Conditions
- Hemorrhagic Cystitis
- Being tested
- Sodium Copper Chlorophyllin
- Medical subject headings
- Cystitis, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Copper ChlorophyllinDrug
Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. It is used as a food colorant and OTC in the USA, Japan, Australia and China for many years for a variety of health benefits including prevention of body odour in geriatric patients, enhanced wound healing, antibacterial action, prevention of cancer in the high-risk populations exposed to hepatocarcinogen aflatoxin B1, treatment of faecal incontinence etc. Studies have shown that CHL has immunostimulatory, anti-inflammatory and antiviral effects in addition to antioxidant and radioprotective properties. It increases the expression of a transcription factor (protein) Nrf2 which improves lymphocyte survival and enables efficient detoxification after exposure to radiation. The duration of therapy will be up to 6 months depending upon the response of participants.
| Study group | Role | What they receive |
|---|---|---|
| Oral Chlorophyllin arm | Experimental | Participants will receive oral Sodium Copper Chlorophyllin at a dose of 750mg once daily (OD) on an empty stomach. Receives: Drug: Sodium Copper Chlorophyllin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
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.
Measured: Baseline
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
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.
Measured: Post 1 month
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
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.
Measured: Post 3 months
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
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.
Measured: Post 6 months
Secondary outcomes (4)
Assessment of Bladder Cancer Index (BCI) scores.
Bladder cancer index (BCI) scores will be calculated at baseline, 1 month and 3 months for each study participant.
Minimum value - 0, Maximum value - 100, Higher scores depict better outcome.
Measured: Baseline, post 1 month, post 3 months
Assessment of Treatment Failure (TF).
Treatment Failure (TF) defined as requirement of alternative intervention for persistent severe hematuria within 3 months from the start of treatment or early stoppage due to intolerable side effects in the absence of PR/CR [Intervention: multiple cystoscopies with clot evacuation, cystectomy, hyperbaric oxygen therapy (HBOT) or transfusion due to persistent drop in hemoglobin].
Measured: Post 3 months
Evaluation of treatment failure-free survival.
Treatment failure-free survival is defined as the time from enrolment to the date of first intervention up to 3 months or date of discontinuation of therapy due to intolerable side effects in the absence of PR/CR.
Measured: Baseline to up to 3 months
Assessment of Quality of Life (QOL) using EORTC -QLQ C-30 questionnaire.
QoL will be measured using the EORTC-QLQ-30 questionnaire at baseline, 1 month and 3 months for each study participant.
Minimum value - 0, Maximum value cannot be predetermined. five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Therefore, higher scores depict better outcomes for some scales whereas for some scales lower scores depict better outcomes.
Measured: Baseline, post 1 month, post 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start26 Mar 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic CystitisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single centre, single-arm, interventional phase II study.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Bhabha Atomic Research Centre
- Responsible party
- Principal investigator, Dr Gagan Prakash, Tata Memorial Centre
- Investigators
- Dr. Gagan Prakash, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348239
- Sponsor's protocol ID
- 900878
- Acronym
- CLARITY
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study-related information will be strictly maintained and will be shared only with the IEC and DSMB authorities.
Publications
Smit 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.
PubMed 20212517Browne 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.
PubMed 26798335Sandhu 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.
PubMed 15476520Feldmeier 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.
PubMed 12507182Oscarsson 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.
PubMed 31537473Villeirs 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.
PubMed 31617263Lojanapiwat 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.
PubMed 12376221Westerman ME, Boorjian SA, Linder BJ. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: A contemporary evaluation. Int Braz J Urol. 2016 Nov-Dec;42(6):1144-1149. doi: 10.1590/S1677-5538.IBJU.2015.0588.
PubMed 27509371Comploj E, Pycha A, Trenti E, Palermo S, Bonatti M, Krause P, Folchini DM, Pycha A. Transarterial Embolization in the Management of Intractable Haemorrhage. Urol Int. 2021;105(1-2):95-99. doi: 10.1159/000511123. Epub 2020 Oct 16.
PubMed 33070141Linder BJ, Tarrell RF, Boorjian SA. Cystectomy for refractory hemorrhagic cystitis: contemporary etiology, presentation and outcomes. J Urol. 2014 Dec;192(6):1687-92. doi: 10.1016/j.juro.2014.06.030. Epub 2014 Jun 14.
PubMed 24936722Chlorophyll and Chlorophyllin Linus Pauling Institute Oregon State University. (Micronutrient Information)
Egner PA, Wang JB, Zhu YR, Zhang BC, Wu Y, Zhang QN, Qian GS, Kuang SY, Gange SJ, Jacobson LP, Helzlsouer KJ, Bailey GS, Groopman JD, Kensler TW. Chlorophyllin intervention reduces aflatoxin-DNA adducts in individuals at high risk for liver cancer. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14601-6. doi: 10.1073/pnas.251536898. Epub 2001 Nov 27.
PubMed 11724948Citrin D, Cotrim AP, Hyodo F, Baum BJ, Krishna MC, Mitchell JB. Radioprotectors and mitigators of radiation-induced normal tissue injury. Oncologist. 2010;15(4):360-71. doi: 10.1634/theoncologist.2009-S104.
PubMed 20413641Oriya A, Takahashi K, Inanami O, Miura T, Abe Y, Kuwabara M, Kashiwakura I. Individual differences in the radiosensitivity of hematopoietic progenitor cells detected in steady-state human peripheral blood. J Radiat Res. 2008 Mar;49(2):113-21. doi: 10.1269/jrr.07079. Epub 2007 Dec 12.
PubMed 18075225Dainiak N. Hematologic consequences of exposure to ionizing radiation. Exp Hematol. 2002 Jun;30(6):513-28. doi: 10.1016/s0301-472x(02)00802-0.
PubMed 12063018
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Oral Chlorophyllin in Hemorrhagic Cystitis Secondary to Radiation Therapy for Pelvic Malignancies
- ClinicalTrials.gov ID
- NCT05348239
- Acronym / sponsor ID
- CLARITY / 900878
- Conditions
- Hemorrhagic Cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Collaborators
- Bhabha Atomic Research Centre
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Apr 2022 (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.
To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.
Detailed description
Radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. Intensity modulation and image guidance have improved the delivery of radiation therapy in recent times. However, this does not eliminate the risk of radiation-induced damage to the adjacent healthy tissue - in this consideration, the bladder. Hemorrhagic cystitis accounts for 5-7% of emergency urology admissions. The procedure for the management of radiation cystitis proceeds from non-invasive oral drugs and HBOT to minimally invasive treatment like intravesical therapy and angioembolization, to more morbid procedures like cystectomy and urinary diversion. Although these treatment modalities have shown some success, most patients continue to have recurrent/persistent hematuria. There is a need to explore options of other oral/intravesical agents which can aid in mucosal healing and stop hematuria with lasting effects. Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. Research at BARC has shown that chlorophyllin prevents radiation-induced toxicity in normal hematopoietic tissues and normal epithelial cells. A phase 1 clinical study in healthy volunteers indicate that CHL is safe and tolerable in humans and has not shown any severe adverse events. The purpose of this study is to evaluate the safety and efficacy of oral sodium copper chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single centre, single-arm, interventional phase II study.
| Arm | Type | Receives |
|---|---|---|
| Oral Chlorophyllin arm | Experimental | Drug: Sodium Copper ChlorophyllinParticipants will receive oral Sodium Copper Chlorophyllin at a dose of 750mg once daily (OD) on an empty stomach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
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 ChlorophyllinSodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. It is used as a food colorant and OTC in the USA, Japan, Australia and China for many years for a variety of health benefits including prevention of body odour in geriatric patients, enhanced wound healing, antibacterial action, prevention of cancer in the high-risk populations exposed to hepatocarcinogen aflatoxin B1, treatment of faecal incontinence etc. Studies have shown that CHL has immunostimulatory, anti-inflammatory and antiviral effects in addition to antioxidant and radioprotective properties. It increases the expression of a transcription factor (protein) Nrf2 which improves lymphocyte survival and enables efficient detoxification after exposure to radiation. The duration of therapy will be up to 6 months depending upon the response of participants. | Drug | Oral Chlorophyllin arm |
Primary outcome
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
Time frame: Baseline
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.
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
Time frame: Post 1 month
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.
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
Time frame: Post 3 months
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.
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.
Time frame: Post 6 months
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.
4 secondary outcomes
Assessment of Bladder Cancer Index (BCI) scores.
Time frame: Baseline, post 1 month, post 3 months
Assessment of Treatment Failure (TF).
Time frame: Post 3 months
Evaluation of treatment failure-free survival.
Time frame: Baseline to up to 3 months
Assessment of Quality of Life (QOL) using EORTC -QLQ C-30 questionnaire.
Time frame: Baseline, post 1 month, post 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 20212517Smit 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.
- Background: PubMed 26798335Browne 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.
- Background: PubMed 15476520Sandhu 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.
- Background: PubMed 12507182Feldmeier 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.
- Background: PubMed 31537473Oscarsson 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.
- Background: PubMed 31617263Villeirs 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.
- Background: PubMed 12376221Lojanapiwat 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.
- Background: PubMed 27509371Westerman ME, Boorjian SA, Linder BJ. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: A contemporary evaluation. Int Braz J Urol. 2016 Nov-Dec;42(6):1144-1149. doi: 10.1590/S1677-5538.IBJU.2015.0588.
- Background: PubMed 33070141Comploj E, Pycha A, Trenti E, Palermo S, Bonatti M, Krause P, Folchini DM, Pycha A. Transarterial Embolization in the Management of Intractable Haemorrhage. Urol Int. 2021;105(1-2):95-99. doi: 10.1159/000511123. Epub 2020 Oct 16.
- Background: PubMed 24936722Linder BJ, Tarrell RF, Boorjian SA. Cystectomy for refractory hemorrhagic cystitis: contemporary etiology, presentation and outcomes. J Urol. 2014 Dec;192(6):1687-92. doi: 10.1016/j.juro.2014.06.030. Epub 2014 Jun 14.
- BackgroundChlorophyll and Chlorophyllin Linus Pauling Institute Oregon State University. (Micronutrient Information)
- Background: PubMed 11724948Egner PA, Wang JB, Zhu YR, Zhang BC, Wu Y, Zhang QN, Qian GS, Kuang SY, Gange SJ, Jacobson LP, Helzlsouer KJ, Bailey GS, Groopman JD, Kensler TW. Chlorophyllin intervention reduces aflatoxin-DNA adducts in individuals at high risk for liver cancer. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14601-6. doi: 10.1073/pnas.251536898. Epub 2001 Nov 27.
- Individual participant dataSharing planned: No. All study-related information will be strictly maintained and will be shared only with the IEC and DSMB authorities.
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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. This study is not recruiting at the moment.
Dr. Gagan Prakash principal investigator
Tata Memorial Centre
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 Hemorrhagic Cystitis, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gagan Prakash (022 2417 ext. 7176, gagan2311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Objective Response Rate (ORR) as per CTCAE v5.0. (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05348239, which also lists 34 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 Apr 2022.