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A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma

Study acronym: CHROME
StatusRecruiting
PhasePhase 2
Started2023-11-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 11, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-04-08
minor
Study Status v3
Re-verified, no change to tracked fields
2023-11-13
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-09→2025-11
Completion date2025-09→2025-11
Start dateestimated 2023-09→confirmed 2023-11-13
Study sites0→1
2023-09-04
minor
Study Status v1
Primary completion date2025-08→2025-09
Completion date2025-08→2025-09
Start date2023-08→2023-09
2023-08-24
minor
Original filing
666 trials monitored
See 45 trials at risk
666 trials monitored
See 38 trials at risk
Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).
Trial Details
NCT Number NCT06016452
Lead Sponsor Tata Memorial Centre
Collaborators: Bhabha Atomic Research Centre
Conditions Diffuse Glioma, Radionecrosis of Brain, High Grade Glioma, Glioblastoma Multiforme
Enrollment 118 participants
Start Date 2023-11-13
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-04-11