NCT06016452 A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma
| NCT ID | NCT06016452 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tata Memorial Centre |
| Condition | Diffuse Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2023-11-13 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Histological diagnosis of diffuse glioma. * Radionecrosis on imaging with new neurological symptoms/ worsening of prior deficits (Stratum A) or * without new symptoms (Stratum B). * Karnofsky Performance Scale (KPS) ≥ 50. Exclusion Criteria: * No tissue diagnosis. * KPS\< 50. * Disease progression * Contraindications to corticosteroids. * Altered mental status with deficits in understanding or inability to consent to the study. * Brainstem glioma * Indeterminate for radionecrosis vs disease progression * Prior treatment with bevacizumab (either for disease progression or radionecrosis)
Contact & Investigator
Archya Dasgupta, MD
PRINCIPAL INVESTIGATOR
Tata Memorial Hospital
Frequently Asked Questions
Who can join the NCT06016452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diffuse Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06016452 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06016452 currently recruiting?
Yes, NCT06016452 is actively recruiting participants. Contact the research team at archya1010@gmail.com for enrollment information.
Where is the NCT06016452 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06016452 clinical trial?
NCT06016452 is sponsored by Tata Memorial Centre. The principal investigator is Archya Dasgupta, MD at Tata Memorial Hospital. The trial plans to enroll 118 participants.