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.
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.
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.
Failure to meet one or more inclusion criteria, rendering the patient ineligible for study participation.
Parallel
Chlorophyllin, Sodium Copper Complex
DrugSodium 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.
Placebo
DrugA 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.
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.
CB-Score (chronic bleeding score)
Additionally, patients may be assessed with exploratory study specific objective + subjective criteria's at each visits as below: Assessment Item Pre - post effectiveness definition per item 1. Amount of bleeding Example: Small streak/ few drops /clots and fresh blood/copious amount in more than 50% episodes. Mandatory improvement of amount and percentage bleeding episodes per day in last one week. 2. Frequency of bleeding Daily/alt day/ weekly once /occasionally: once in two weeks or less. Mandatory improvement in frequency estimated in last one week. 3. Associated symptoms (pain/tenusmus/other) with CTCAE grade Optional improvement in CTCEA grade. 4. CTCAE grade Bleeding Should not deteriorate (intervention should be started only after stabilizing HB above 10 g/dl) 5. CTCAE grade Anemia Should not deteriorate (intervention should be started only after stabilizing HB above 10 g/dl) 6. Surgical Intervention Must not have been required (needed)
Occult Blood Test Conversion Rate
Patients identified to be occult blood positive in stool at randomization and their conversion to test negative at Visit 2-6, may be estimated as a surrogate for subclinical mucosal healing shadowing clinical response. These may further be correlated with clinical response, QoL scores and endoscopic response assessment.
Symptom Relief in Associated GI Symptom Complex
To assess improvements in related gastrointestinal symptoms such as pain, urgency, frequency, tenesmus, diarrhea and other additional associated late toxicity symptoms, PROMs following treatment and their inter-correlations.
Endoscopic Response
To document and quantify endoscopic mucosal healing or improvement using RTOG grading where, Grade 0: No change or just congested mucosa, Grade 1: Minor changes, such as microulceration or mild telangiectasia (small, dilated blood vessels), Grade 2: Superficial ulceration (\>1cm2) or significant telangiectasia, Grade 3: Deep ulceration, severe congestion, or marked bleeding and Grade 4: Necrosis, fistula, or perforation This is derived from OMED scoring coorelated with RTOG/EORTC morbidity scoring
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