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SCRT in TNT With or Without Chlorophyllin

Study acronym: SCOTCH
StatusActive, Not Recruiting
PhasePhase 2
Started2023-07-05
View on ClinicalTrials.gov ↗

Amendment history

2025-09-25
Study Status, Study Design v7
Primary completion dateestimated 2026-03→confirmed 2025-09-09
Completion date2027-04→2027-09-09
2025-04-07
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-03→2026-03
Study sitesdetails revised at 1 of 1 site
2025-01-16
Study Identification, Study Status, Study Description, Outcome Measures v5
Secondary endpoints8 to 9 entries
To evaluate the timeline of Occurence
Study description+223 characters
[...] andard treatment would help in 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 [...] completion of study, outcomes from both the study arm will be compared and participants will be followed by standard protocol for 23 years.
2024-02-15
2 amendments v3-v4
2 re-verifications since 2024-02-01, no change to tracked fields
2023-11-20
Study Status v2
Start dateestimated 2023-06→confirmed 2023-07-05
2023-06-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-05→2023-06
Study sitesdetails revised at 1 of 1 site
2023-05-03
Original filing
The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer. This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment. Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.
Trial Details
NCT Number NCT05856305
Lead Sponsor Tata Memorial Centre
Conditions Rectal Neoplasms
Enrollment 76 participants
Start Date 2023-07-05
Primary Completion 2025-09-09 (estimated)
Study Completion 2027-09-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-23