Chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

Phase 2

Conditions: Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Registration Number: CTRI/2022/02/040314

Lead Sponsor: Bhabha Atomic Research Center BARC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.Any grade of radiation induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3)

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 patient with liver metastasis.

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br/ ><br>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 v5.0Timepoint: Baseline,post 1,3&6 month

Secondary Outcome Measures

Name	Time	Method
1.Bladder cancer index (BCI) scores will be calculated at baseline, 1 month and 3 months for each study participant <br/ ><br> <br/ ><br>2.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 <br/ ><br>[Intervention: multiple cystoscopies with clot evacuation, cystectomy, hyperbaric oxygen therapy (HBOT) or transfusion due to persistent drop in hemoglobin] <br/ ><br> <br/ ><br>3.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 <br/ ><br> <br/ ><br>4.QoL will be measured using the EORTC-QLQ-30 questionnaire at baseline, 1 month and 3 months for each study participant <br/ ><br>Timepoint: 2 years