Oral Chlorophyllin for the Prevention of Toxicity in Radiotherapy for Bladder Cancer.

Phase 2

Conditions: Health Condition 1: C679- Malignant neoplasm of bladder, unspecified

Registration Number: CTRI/2023/08/056133

Lead Sponsor: Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients should have histologically proven Urothelial carcinoma or Urothelial Carcinoma with squamous and Adeno. Differentiation and should be eligible for bladder preservation using radiotherapy/chemoradiotherapy.

2.Patients should have clinical stage T1-T4 cancer.

3.Patients nodal stage should be N0-N1.

4.Patients must be treated with conventional or moderately hypofractionated radiotherapy.

5.Patient should not have any history of pelvic radiation.

6.Adequate Renal Function S.Creatinine <=1.5x upper limit of normal(1.3 mg/dl in men;1.1 mg/dl in female)

7.Adequate Hepatic Function: Total billirubin <=1.5 x institutional upper limit of normal (1.2 mg/dl)

8.Patients must be able to understand and willingness to sign the written informed consent.

Exclusion Criteria

1.Patients with known hypersensitivity or contraindications to chlorophyllin

2.Patients with distant metastasisÂ¬Â¬Â¬Â¬

3.Patients treated with palliative intent or partial bladder RT

4.Chronic active infections such as HIV, Hepatitis B, Hepatitis C

5.Women who are pregnant or breast-feeding

6.Uncontrolled Diabetes Mellitus (RBS:>=180 mg/dl), Hypertension(>=140/90 mm hg) on regular medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the cumulative acute urinary & gastrointestinal toxicities.Timepoint: Two years

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the late urinary & gastrointestinal toxicities <br/ ><br>2.To evaluate bladder cancer outcomes <br/ ><br>3.To evaluate the quality of life <br/ ><br>4.To evaluate the toxicity due to chlorophyllin <br/ ><br>Timepoint: Two years