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

Oral Chlorophyllin for the Prevention of Toxicity in Radiotherapy for Bladder Cancer: A Phase II trial - NIl

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056133

Enrollment

Registered

2023-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL Intervention2: SODIUM COPPER CHLOROPHYLLIN: NIL Intervention3: SODIUM COPPER CHLOROPHYLLIN: All patients in addition to the standard treatment will receive oral sodium copper c

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patients with known hypersensitivity or contraindications to chlorophyllin 2. Patients with distant metastasis¬¬¬¬ 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

Design outcomes

Primary

Measure	Time frame
To evaluate the cumulative acute urinary & gastrointestinal toxicities.Timepoint: Two years	—

Secondary

Measure	Time frame
1. To evaluate the late urinary & gastrointestinal toxicities 2.To evaluate bladder cancer outcomes 3.To evaluate the quality of life 4.To evaluate the toxicity due to chlorophyllin Timepoint: Two years	—

Countries

India

Contacts

Public ContactDr. Mihir Solanki

ACTREC, Tata Memorial Centre

vedangmurthy@gmail.com02224177028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026