Radiation ProctitisPhase 3NCT07837713
A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding
A Phase 3 study testing Chlorophyllin, Sodium Copper Complex in people with Radiation Proctitis and Gastrointestinal Hemorrhage, run by Tata Memorial Centre at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Proctitis, Gastrointestinal Hemorrhage, Radiation Injuries
- What is being tested?
- Chlorophyllin, Sodium Copper Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2026to 1 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
- Prophylactic use of Ecosprin, heparin, warfarin for certain medical conditions may be allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Prof. Rahul Krishnatry, MD, 022-24177000 ext. 7028, krishnatry@gmail.com
About this study
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
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.
Read the detailed description
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.
- Being tested
- Chlorophyllin, Sodium Copper Complex, Placebo
- Keywords
- Radiation-Induced Gastrointestinal Bleeding, Late Radiation Toxicity, Sodium Copper Chlorophyllin, Nrf2 Activator, Gastrointestinal Hemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorophyllin, Sodium Copper ComplexDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after randomization
Secondary outcomes (13)
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
- 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.
- Frequency of bleeding Daily/alt day/ weekly once /occasionally: once in two weeks or less. Mandatory improvement in frequency estimated in last one week.
- Associated symptoms (pain/tenusmus/other) with CTCAE grade Optional improvement in CTCEA grade.
- CTCAE grade Bleeding Should not deteriorate (intervention should be started only after stabilizing HB above 10 g/dl)
- CTCAE grade Anemia Should not deteriorate (intervention should be started only after stabilizing HB above 10 g/dl)
- Surgical Intervention Must not have been required (needed)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 Years
Transfusion Rates
To monitor and compare the number and frequency of blood transfusions required post-treatment between study arms during both parts.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2 Years
Breakthrough Bleeding
To evaluate the frequency of breakthrough or recurrent GI bleeding episodes.
Measured: 2 Years
Rescue Therapy Requirements
To evaluate the need for re-initiation of Nrf2 therapy or alternative adjunctive treatments such as CHL.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion10 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Rahul Krishnatry, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837713
- Sponsor's protocol ID
- 5334
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07837713
- Acronym / sponsor ID
- 5334
- Keywords
- Radiation-Induced Gastrointestinal Bleeding, Late Radiation Toxicity, Sodium Copper Chlorophyllin, Nrf2 Activator, Gastrointestinal Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sodium Copper Chlorophyllin (CHL) | Experimental | Drug: Chlorophyllin, Sodium Copper ComplexParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Prophylactic use of Ecosprin, heparin, warfarin for certain medical conditions may be allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorophyllin, Sodium Copper ComplexSodium 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 | Sodium Copper Chlorophyllin (CHL) |
| PlaceboA 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. | Drug | Placebo |
Primary outcome
Grade 2 or higher anemia (CTCAE anemia version 5) due to uncontrolled bleeding
Time frame: Up to 6 months after randomization
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.
13 secondary outcomes
CB-Score (chronic bleeding score)
Time frame: 2 Years
Occult Blood Test Conversion Rate
Time frame: 2 Years
Symptom Relief in Associated GI Symptom Complex
Time frame: 2 Years
Endoscopic Response
Time frame: 2 Years
Anemia profile
Time frame: 2 Years
Cost of Therapy
Time frame: 2 Years
Transfusion Rates
Time frame: 2 Years
Quality of Life (QoL) QLQ-C30
Time frame: 2 Years
Quality of Life (QoL) QLQ-PRT-20
Time frame: 2 Years
Questionnaire LENT-SOMA
Time frame: 2 Years
Questionnaire EQ-5D-5L
Time frame: 2 Years
Breakthrough Bleeding
Time frame: 2 Years
Rescue Therapy Requirements
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Rahul Krishnatry principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorophyllin, Sodium Copper Complex in people with Radiation Proctitis and Gastrointestinal Hemorrhage, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Rahul Krishnatry, M.D. (022-24177000 ext. 7028, krishnatry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or higher anemia (CTCAE anemia version 5) due to uncontrolled bleeding (time frame: Up to 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.