Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs

NCT05348239 | Unknown Phase 2 DMC

• 1 other identifier: 900878
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhagic Cystitis

Outcome Measures

Primary Outcomes (4)

• Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.

  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) 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 v5.0.

  Baseline

• Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.

  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) 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 v5.0.

  Post 1 month

• Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.

  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) 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 v5.0.

  Post 3 months

• Assessment of Objective Response Rate (ORR) as per CTCAE v5.0.

  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) 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 v5.0.

  Post 6 months

Secondary Outcomes (4)

• Assessment of Bladder Cancer Index (BCI) scores.

  Baseline, post 1 month, post 3 months

• Assessment of Treatment Failure (TF).

  Post 3 months

• Evaluation of treatment failure-free survival.

  Baseline to up to 3 months

• Assessment of Quality of Life (QOL) using EORTC -QLQ C-30 questionnaire.

  Baseline, post 1 month, post 3 months

Study Arms (1)

Oral Chlorophyllin arm

EXPERIMENTAL

Participants will receive oral Sodium Copper Chlorophyllin at a dose of 750mg once daily (OD) on an empty stomach.

Drug: Sodium Copper Chlorophyllin

Interventions

Sodium Copper Chlorophyllin DRUG

Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. It is used as a food colorant and OTC in the USA, Japan, Australia and China for many years for a variety of health benefits including prevention of body odour in geriatric patients, enhanced wound healing, antibacterial action, prevention of cancer in the high-risk populations exposed to hepatocarcinogen aflatoxin B1, treatment of faecal incontinence etc. Studies have shown that CHL has immunostimulatory, anti-inflammatory and antiviral effects in addition to antioxidant and radioprotective properties. It increases the expression of a transcription factor (protein) Nrf2 which improves lymphocyte survival and enables efficient detoxification after exposure to radiation. The duration of therapy will be up to 6 months depending upon the response of participants.

Oral Chlorophyllin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back.
• Any grade of radiation-induced cystitis as per RTOG criteria (RTOG Grade 1-4 equivalent to CTCAE Grade 1-3).
• 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 patients with liver metastasis.
• Adequate renal function defined as creatine clearance ≥ 30 mL/min (By Cockcroft-Gault formula).

You may not qualify if:

• Known hypersensitivity or contraindications against sodium chlorophyllin.
• Hemodynamically unstable patients not responding to initial resuscitation.
• Patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (CTCAE grade 4).

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Bhabha Atomic Research Centre (BARC), Mumbai: collaborator

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (34)

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• Interim Clinical Study Report (Project No. 0462-16) - An Open Label, Clinical Study To Assess Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Sodium Copper Chlorophyllin In Healthy Adult, Human Male Subjects.

  BACKGROUND

MeSH Terms

Conditions

Cystitis, Hemorrhagic

Interventions

chlorophyllin

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dr. Gagan Prakash

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gagan Prakash

CONTACT

022 2417; gagan2311@gmail.com

Dr. Vikram Gota

CONTACT

+91 7715019117; vikramgota@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Urologic Oncology

Model Details: A prospective, single centre, single-arm, interventional phase II study.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 27, 2022
• Study Start: March 26, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)