A Phase 3 interventional study of Chlorophyllin, Sodium Copper Complex and Placebo in Radiation Proctitis, Gastrointestinal Hemorrhage and Radiation Injuries, sponsored by Tata Memorial Centre. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Tata Memorial Centre · Phase 3, Interventional, and Treatment
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.
Late radiation-induced gastrointestinal (GI) bleeding is a chronic complication that may develop months to years after radiotherapy for abdominal, pelvic, or mediastinal malignancies. Patients may experience persistent GI bleeding, anemia, recurrent blood transfusions, impaired quality of life, and repeated invasive procedures. Existing treatments, including argon plasma coagulation, hyperbaric oxygen therapy, and supportive medical management, have variable efficacy, limited availability, and may be associated with substantial cost or procedure-related risks.
Sodium copper chlorophyllin (CHL) is a semi-synthetic chlorophyll derivative that activates the Nrf2 pathway and has demonstrated antioxidant, anti-inflammatory, and radioprotective properties in preclinical studies. Early-phase clinical studies have shown a favorable safety profile and encouraging efficacy in radiation-induced toxicities, including hemorrhagic cystitis, supporting further evaluation in radiation-induced GI bleeding.
This is a multicenter, randomized, double-blind, placebo-controlled Phase III superiority trial. Approximately 200 participants with late radiation-induced luminal GI bleeding will be randomized in a 1:1 ratio to receive either oral CHL 500 mg once daily or matching placebo for 3 months, in addition to standard medical management. Participants will be followed for up to 2 years after randomization.
The primary endpoint is the occurrence of grade 2 or higher anemia attributable to radiation-induced GI bleeding at 6 months. Secondary endpoints include changes in bleeding severity, gastrointestinal symptoms, endoscopic response, occult blood test conversion, anemia-related laboratory parameters, blood transfusion requirements, quality of life, safety, breakthrough bleeding, rescue therapy requirements, and cost-effectiveness.
The study is designed to determine whether CHL can provide an effective, safe, and affordable treatment option for patients with chronic radiation-induced GI bleeding while reducing anemia, transfusion requirements, and healthcare costs and improving patient quality of life.
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 200 is above the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Tata Memorial Centre is the lead sponsor of 64 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Up to 6 months after randomization
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)
Time frame: 2 Years
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.
Time frame: 2 Years
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.
Time frame: 2 Years
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
Time frame: 2 Years
Anemia profile
It includes iron studies (serum iron, ferritin, total iron-binding capacity \[TIBC\], transferrin), serum vitamin B12, and serum folate levels. The nutritional background at baseline may be captured, and its improvement with treatment and supplementation may be charted and reported.
Time frame: 2 Years
Cost of Therapy
To evaluate the overall cost-effectiveness of CHL, including medication, monitoring, and adverse event management costs. The direct cost of various medicines/transfusions/admissions/procedures related to Late GI bleeding and its complications incurred by patients will be collated from electronic charts of patients and estimated to be compared. Cost effectiveness will also be estimated and compared using EQ-5D-5L questionnaire. This measures health in five domains namely mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These responses are converted to a single index score (utility) which are then multiplied by time spent in that state to estimate the QALY. The exploratory analysis of estimating recovering quality of life utility index and incremental cost effectiveness ratio may be defined and estimated with available data.
Time frame: 2 Years
Transfusion Rates
To monitor and compare the number and frequency of blood transfusions required post-treatment between study arms during both parts.
Time frame: 2 Years
Quality of Life (QoL) QLQ-C30
To assess health-related quality of life using validated patient-reported outcome measures, QLQ C30 Questionnaires at baseline and at every Visits ( 2-6 month) (+/- 1 month). Patient-reported outcomes will be analysed after obtaining the responses. EORTC questionnaires are available in Hindi, Marathi and Bangla languages. They will be provided to the literate patient in the language of their choice by the study coordinator for filling. In case of any difficulty in understanding any word or sentence, it would be explained by the study team. In the case of illiterate patients, patient relatives will be allowed to fill the form on the patient's behalf based on the patient's responses to the questions. The forms will be filled during the waiting period in OPD or for other investigations. Other scores are available only in English and will be filled by the patient directly if the patient or relatives know how to read and write English, or else
Time frame: 2 Years
Quality of Life (QoL) QLQ-PRT-20
To assess health-related quality of life using validated patient-reported outcome measures EORTC questionnaire PRT-20 at baseline, one month on treatment (+/-1 week), 3 months (completion of study intervention; +/-2 weeks), and 6 months (+/- 1month), and then 6 monthly till two years (+/- 1 month).
Time frame: 2 Years
Questionnaire LENT-SOMA
To assess health-related quality of life using validated patient-reported outcome measures questionnaire LENT-SOMA at baseline, one month on treatment (+/-1 week), 3 months (completion of study intervention; +/-2 weeks), and 6 months (+/- 1month), and then 6 monthly till two years (+/- 1 month).
Time frame: 2 Years
Questionnaire EQ-5D-5L
To assess health-related quality of life using validated patient-reported outcome measures questionnaire EQ-5D-5L at baseline, one month on treatment (+/-1 week), 3 months (completion of study intervention; +/-2 weeks), and 6 months (+/- 1month), and then 6 monthly till two years (+/- 1 month).
Time frame: 2 Years
Breakthrough Bleeding
To evaluate the frequency of breakthrough or recurrent GI bleeding episodes.
Time frame: 2 Years
Rescue Therapy Requirements
To evaluate the need for re-initiation of Nrf2 therapy or alternative adjunctive treatments such as CHL.
Time frame: 2 Years
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Sep 2028, 23 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorophyllin
Tata Memorial Centre