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CTRI Number  CTRI/2023/04/051458 [Registered on: 10/04/2023] Trial Registered Prospectively
Last Modified On: 07/07/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   SCRT in TNT with or without chlorophyllin 
Scientific Title of Study   Short course radiotherapy based total neoadjuvent therapy with or without chlorophyllin 
Trial Acronym  SCOTCH study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Krishnatry  
Designation  Professor (F) 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177028  
Fax    
Email  krishnatry@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Krishnatry  
Designation  Professor (F) 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177028  
Fax    
Email  krishnatry@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Krishnatry  
Designation  Professor (F) 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiation Oncology F, 11 floor, Room No: 1125, Homi Bhabha Block, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177028  
Fax    
Email  krishnatry@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai Maharashtra India 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai Maharashtra India 400012  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Krishnatry   Tata Memorial Hospital  Department of Radiation Oncology F, 11 floor, room no: 1125, Homi Bhabha Block, Parel, Mumbai
Mumbai
MAHARASHTRA 		 022-24177028

krishnatry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chorophyllin  Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from the green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. Chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. It has been used as a food colourant and OTC in the USA, Japan, Australia and China for many years for a variety of health benefits including prevention of body odour in geriatric patients, enhanced wound healing, antibacterial action, prevention of cancer in the high-risk population exposed to hepatocarcinogenaflatoxin B1, treatment of faecal incontinence etc. Studies have shown that CHL has immunostimulatory, anti-inflammatory and antiviral effects in addition to antioxidant and cytotoxic protective and radioprotective properties [20][21]. It increases the expression of a transcription factor (protein) Nrf2 which improves lymphocyte survival and enables efficient detoxification after exposure to radiation. Chlorophyllin also delays microtubule polymerisation and therefore slows down cell division (mitotic catastrophe) in normal cells and protects them from death from cytotoxic agents. Chlorophyllin regimen Dose:750 mg Route of administration: oral Frequency: Once daily in the morning before food. Duration: 10-14 days before RT (mostly at simulation) and to continue for up to 3 months after the last dose of cytotoxic therapy as chemotherapy or radiotherapy. 
Comparator Agent  Placebo  Look-alike inert substance tablets in shape and colour, packaged in a similar bottle as the testing drug will be provided by the lab. A similar regimen will be followed as the intervention drug. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age > 18 years.
2.Histologically confirmed diagnosis of adenocarcinoma of the rectum.
3.Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
4.Non-circumferential tumours with craniocaudal length <7 cm
5.The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
6.No evidence of distant metastases on CT Chest and Abdomen.
7.No prior pelvic radiation therapy
8.No prior chemotherapy or surgery for rectal cancer
9.ECOG Performance status 0-2
10.Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
11.Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
11.1. ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3.
11.2. Total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert’s Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN. 
 
ExclusionCriteria 
Details  -Signet or mucinous histology cancer of rectum
-Recurrent rectal cancer or previous pelvic radiotherapy
-Primary unresectable rectal cancer.
-Creatinine level greater than 1.5 times the upper limit of normal.
-Patients who are unable to undergo an MRI.
-Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina stable or unstable, MI, TIA, or CVA.
-Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
-Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
-Patients with any other concurrent medical or psychiatric condition or disease which, in the investigators judgment would make them inappropriate candidates for entry into this study.
-Poor reliability for follow up.
-Ineligible as per eligibility criteria
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of grade 2 or higher acute GI/GU/haematological toxicity  3 months post-last cytotoxic therapy.  
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the 2-year overall complete response rates (clinical or pathological) in whole cohort and if any difference between chlorophyllin and control arms.  2 years 
To estimate the 2-year organ preservation rates, TME free survival and if any difference between chlorophyllin and control arms.  2 years 
To estimate the 2-year disease free survival, Distant metastasis free survival, loco-regional failure free survival, and overall survival rates in the whole cohort, and if any difference between two arms and between patients with successful NOM versus others.  2 years 
To compare treatment-related early and late toxicities (grade 2 CTCAE v5) for two years between the groups as (3).  2 years 
To estimate surgical complications based on Clavien-Dindo classification  30 days post surgery 
To estimate and compare Health Related Quality Of Life (EORTC QOL-C30, CR 29, PRT 20, SH 22), and LARS, IPSS scores between various groups as (3).  2 years 
To estimate direct cost benefit with reduction in toxicity  2 years 
To study the tumour volume reduction kinetics and radiotherapy doses and probability of successful NOM outcomes.  2 years 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   The trial results will be submitted for publication in international peer-reviewed journals and presented at national/international conferences. Patient’s personal information/identity will be kept confidential and will not be disclosed or made public at the time of publications. No publication restrictions will be imposed. The principal investigators will take the roles of the corresponding author and first author positions as decided mutually. Authorship criteria for other publications stemming from the study will be decided as per the relative contributions and existing institutional guidelines. The contribution of all investigators will be acknowledged in such manuscripts if they are not eligible for authorship. In addition, the grant-giving will also be acknowledged in all publications. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The current standard treatment for locally advanced rectal cancer includes neoadjuvant (treatment given before Surgery) radiotherapy &chemotherapy followed by surgery if needed or wait and watch in patients whom tumour has completely regressed. It has been observed that even after receiving this intensive treatment patients, almost 70% of patients develop acute toxicity (during or within 3 months) of grade 2 or higher (needing medication for toxicity). This affects their treatment tolerance, completion and quality of life. In this study we are going to see if addition of drug Chlorophyllin along with standard treatment, would help reducing the acute toxicity. Chlorophyllin is present in all green leaves of plants giving them green color. The drug is derived from green plant leaves. As it is a plant based product it is safe for humans and has no known side effects of its own. This is a randomized study which has two arms; Arm 1 is test arm where will receive drug of interest (Chlorophyllin) and in other arm you will receive Placebo. Upon successful completion of study, outcomes from both the study arm will compared and you will be followed by standard protocol for 2 years. 
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