Clinical TrialID 8095

SCRT in TNT With or Without Chlorophyllin

NCT05856305

Rectal Neoplasms

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Record Fields

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Clinical Trial Id
8095
Evidence Id
8095
Core Evidence Id
8095
Source Clinical Trial Id
8094
Herb2 Clinical Trial Id
HBCT008094
Nct Id
NCT05856305
Title
SCRT in TNT With or Without Chlorophyllin
Status
Recruiting
Phase
Phase 2
Study Result
No
Study Condition
Rectal Neoplasms
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Chlorophyllin, Sodium Copper Complex|DRUG: Placebo
Intervention Allocation
Randomized
Intervention Model
Sequential
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
76
Outcome Measure
Acute Toxicity, Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT). Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 late toxicity means a good outcome. Grade 2 or higher late toxicity means a worse outcome., 3 months post-last cytotoxic therapy.
Sponsor Collaborator
Tata Memorial Centre
Funded By
OTHER
Location
Tata Memorial Hospital, Mumbai, Maharashtra, 400012, India
Other Id
900959
Start Date
2023-07-05
Primary Completion Date
2025-03
Completion Date
2027-04
First Posted
2023-05-12
Results First Posted
Last Update Posted
2024-02-16
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05856305
Title Cn
Title En
SCRT in TNT With or Without Chlorophyllin
Bilingual Status
semi_complete