Clinical Trials Logo

Clinical Trial Summary

To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05348239
Study type Interventional
Source Tata Memorial Centre
Contact Dr. Gagan Prakash
Phone 022 2417
Email gagan2311@gmail.com
Status Recruiting
Phase Phase 2
Start date March 26, 2022
Completion date March 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT03129126 - The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis Phase 2
Completed NCT02172963 - A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis Phase 1/Phase 2
Recruiting NCT04696666 - Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis N/A
Recruiting NCT02174536 - A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis Phase 2
Terminated NCT04390113 - Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) Phase 3
Not yet recruiting NCT06241274 - Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT N/A
Not yet recruiting NCT06198517 - Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT N/A
Recruiting NCT05726786 - The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) Phase 3