A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding

NCT07837713 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 5334
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial will evaluate whether oral sodium copper chlorophyllin (CHL) is effective and safe for treating late radiation-induced gastrointestinal (GI) bleeding in patients who previously received radiotherapy for cancer. Radiation-induced GI bleeding can occur months or years after treatment and may lead to chronic bleeding, anemia, blood transfusions, and reduced quality of life. Current treatment options are often invasive, expensive, or only partially effective. Eligible participants will be randomly assigned to receive either CHL 500 mg once daily or a matching placebo for 3 months, in addition to standard medical management, and will be followed for up to 2 years. The primary objective is to determine whether CHL reduces clinically significant anemia caused by radiation-induced GI bleeding at 6 months. Secondary objectives include evaluation of bleeding severity, gastrointestinal symptoms, endoscopic healing, blood transfusion requirements, quality of life, safety, and cost-effectiveness. The study aims to determine whether CHL can provide an effective, safe, and affordable treatment option for patients with chronic radiation-induced GI bleeding.

Conditions

Radiation Proctitis; Gastrointestinal Hemorrhage; Radiation Injuries

Keywords

Radiation-Induced Gastrointestinal Bleeding; Late Radiation Toxicity; Sodium Copper Chlorophyllin; Nrf2 Activator; Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Grade 2 or higher anemia (CTCAE anemia version 5) due to uncontrolled bleeding

  Grade 2 or higher anemia (CTCAE anemia version 5) due to uncontrolled bleeding defines failure of intervention. This will be actively evaluated at 1,3 and 6 months and for the intervention to be successful, Hb should be \>/=10gm/dl (at the same lab, where baseline Hb was evaluated) at 6 months from randomization. Interim Hb levels for unplanned patients visits and 1, 3 months will also be counted, where if Hb \<8gm/gl, then the intervention will be deemed unsuccessful without waiting for 6 months and patient will be managed as per institutional protocol. Patients may still be followed up for recording institutional practice (interventions) and outcomes till 2 years follow up is completed.

  Up to 6 months after randomization

Secondary Outcomes (13)

• CB-Score (chronic bleeding score)

  2 Years

• Occult Blood Test Conversion Rate

  2 Years

• Symptom Relief in Associated GI Symptom Complex

  2 Years

• Endoscopic Response

  2 Years

• Anemia profile

  2 Years

Study Arms (2)

Sodium Copper Chlorophyllin (CHL)

EXPERIMENTAL

Participants randomized to this arm will receive oral sodium copper chlorophyllin (CHL) 500 mg once daily for 3 months in addition to standard medical management for late radiation-induced gastrointestinal bleeding. Standard care may include supportive measures such as blood transfusions, hematinics, laxatives, tranexamic acid, sucralfate or enterofoam enema, and optimization of anticoagulant therapy as clinically indicated. Participants will be followed for up to 2 years.

Drug: Chlorophyllin, Sodium Copper Complex

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive matching placebo tablets once daily for 3 months in addition to standard medical management for late radiation-induced gastrointestinal bleeding. The placebo is identical in appearance, packaging, and labeling to the investigational product to maintain blinding. Participants will receive the same standard medical management and follow-up schedule as the experimental arm.

Drug: Placebo

Interventions

Placebo DRUG

A matching placebo tablet identical in appearance, packaging, and administration schedule to the chlorophyllin tablet. Participants will receive one placebo tablet orally once daily for 3 months in addition to standard medical management. The placebo is designed to maintain blinding in this double-blind, randomized trial.

Placebo

Chlorophyllin, Sodium Copper Complex DRUG

Sodium copper chlorophyllin 500 mg oral tablet administered once daily for 3 months in addition to standard medical management for late radiation-induced gastrointestinal bleeding. Participants are randomized to receive either chlorophyllin or a matching placebo in a double-blind manner.

Sodium Copper Chlorophyllin (CHL)

Eligibility Criteria

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

You may qualify if:

• Age greater than 18 years.
• Histologically confirmed malignancy who have previously received radiotherapy to the pelvis, abdomen, or mediastinum and subsequently developed late radiation-induced luminal gastrointestinal bleeding at least 6 months after completion of radiotherapy.
• Currently no evidence of distant metastases or local recurrence associated with GI bleed, documented and proven as appropriate with the primary diagnosis.
• Site of GI bleed localised by either CT angiography or endscopy (Vienna score) or as per best standards applicable in institutional practice and primary diagnosis.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• Ability to understand, voluntarily consent, and sign a written informed consent form prior to study participation.
• Additional local symptoms associated with site of bleeding along with bleeding are allowed.
• HB maintained \>10 g/dl with or without transfusion before initiation of study intervention. Occult stool may be positive.
• Previous bleed treatment failure (any, including HBOT/APC), or partial response to APC/HBOT or other treatment is allowed.
• Patient reliable for follow-up for 2 years

You may not qualify if:

• Diagnosed of ulcerative colitis or other histologically confirmed inflammatory bowel disease (IBD), disease such as ITP, TTP etc where patient may have bleeding tendencies which may be associated with GI bleed independently.
• Presence of any other significant medical or psychiatric condition that, in the opinion of the investigator, may compromise the patient's safety, interfere with study participation or compliance, or confound interpretation of study results.
• Poor anticipated compliance or follow-up reliability, as assessed by the investigator.
• Prophylactic use of Ecosprin, heparin, warfarin for certain medical conditions may be allowed.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Radiation Injuries

Interventions

chlorophyllin

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Prof. Rahul Krishnatry

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Rahul Krishnatry, M.D.

CONTACT

022-24177000; krishnatry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, placebo-controlled study. Participants, treating physicians, investigators involved in patient care, and blinded study statisticians will remain unaware of treatment assignment throughout the study. Sodium copper chlorophyllin (CHL) tablets and placebo tablets are identical in appearance, packaging, and labeling and are dispensed using unique bottle identification numbers. Treatment allocation is maintained by an independent unblinded statistician, who provides bottle numbers to the study pharmacist for dispensing. The randomization code will remain concealed until database lock or unless emergency unblinding is required for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either oral sodium copper chlorophyllin (CHL) 500 mg once daily or a matching placebo for 3 months, in addition to standard medical management. Participants will remain in their assigned treatment group throughout the study and will be followed for up to 2 years to evaluate efficacy and safety outcomes.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 23, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 10, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)