Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system
Conditions
Interventions
Intervention1: Sodium Copper Chlorophyllin: Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium cop
Sponsors
Bhabha Atomic Research Center BARC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >= 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back 2. Grade II to grade IV hematuria as per the CTCAE v5.0 grading for hematuria will be included, CTCAE term Hematuria will be used instead of non-infective cystitis 3. Adequate liver function defined as ALT/ALT 4. Adequate renal function defined as creatine clearance >= 30 mL/min (By Cockcroft-Gault formula) Further evaluation of severity of hemorrhagic cystitis and response assessment during the study will be done using CTCAE criteria
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindications against sodium chlorophyllin 2. Hemodynamically unstable patients not responding to initial resuscitation 3. Patients with life threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline assessment is from day 60 to day 1 before enrolment. Response assessment is from day 30 to day 90 after starting treatment. Complete response is absence of gross hematuria. Partial response is at least one grade reduction. Stable disease is no change in worst grade. Progression is a worse grade in the response phase. Hematuria lasting less than 48 hours is not considered for grading.Timepoint: Baseline,post 1,3&6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bladder cancer index (BCI) scores will be calculated at baseline, 1 month & 3 months for each study participant 2. Treatment failure & treatment failure free survival will be combined into another endpoint called time to treatment failure defined as time from enrolment to the time of alternative intervention or death from any cause 3. Alternative Interventios: multiple cystoscopies with clot evacuation, cystectomy, hyperbaric oxygen therapy (HBOT) or transfusion due to persistent drop in hemoglobin] 4. QoL will be measured using the EORTC-QLQ-30 questionnaire at baseline, 1 month & 3 months for each study participant 5. Define SAE only if clot evacuation is required at least after three weeks of starting the medication. The duration of three weeks has been chosen as all patients who have responded clinically have done so between second & third week of starting the medication. Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Gagan Prakash
Tata Memorial Hospital
Outcome results
None listed