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NCT07837713

PHASE3

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

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

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.

Official title: Nrf2 Activator (Chlorophyllin) or Placebo With Standard Treatment for Late Radiation-induced Luminal Gastrointestinal Tract Bleeding: Multicentric Double-Blinded Phase III Randomised Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-09-15

Completion Date

2030-09-01

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Radiation Proctitis Gastrointestinal Hemorrhage Radiation Injuries

Interventions

DRUG

Chlorophyllin, Sodium Copper Complex

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.

DRUG

Placebo

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.

Inclusion Criteria: 1. Age greater than 18 years. 2. 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. 3. Currently no evidence of distant metastases or local recurrence associated with GI bleed, documented and proven as appropriate with the primary diagnosis. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 6. Ability to understand, voluntarily consent, and sign a written informed consent form prior to study participation. 7. Additional local symptoms associated with site of bleeding along with bleeding are allowed. 8. HB maintained \>10 g/dl with or without transfusion before initiation of study intervention. Occult stool may be positive. 9. Previous bleed treatment failure (any, including HBOT/APC), or partial response to APC/HBOT or other treatment is allowed. 10. Patient reliable for follow-up for 2 years Exclusion Criteria: 1. 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. 2. 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. 3. Poor anticipated compliance or follow-up reliability, as assessed by the investigator. 4. Failure to meet one or more inclusion criteria, rendering the patient ineligible for study participation. 5. Prophylactic use of Ecosprin, heparin, warfarin for certain medical conditions may be allowed.

Locations (1)

Tata Memorial Hospital

Mumbai, Maharashtra, India