Using Chlorophyllin to Treat Brain Damage from Radiation in Glioma Patients
A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma
This study is testing if Chlorophyllin can help glioma patients with brain damage from radiation feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy, radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06016452 on ClinicalTrials.gov |
What this trial studies
This phase 2 study investigates the effectiveness of Chlorophyllin in managing radionecrosis, a complication that can arise after radiation therapy in patients with diffuse gliomas. The study will include patients who exhibit symptoms of radionecrosis or those who are asymptomatic but have imaging evidence of the condition. Participants will be evaluated based on their neurological symptoms and performance status, with the aim of determining the drug's ability to alleviate symptoms and improve quality of life. The study seeks to provide an alternative treatment option to corticosteroids, which have significant side effects.
Who should consider this trial
Good fit: Ideal candidates include patients with a histological diagnosis of diffuse glioma who are experiencing radionecrosis with or without neurological symptoms.
Not a fit: Patients with disease progression, contraindications to corticosteroids, or those unable to consent due to altered mental status may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective management option for patients suffering from radionecrosis after glioma treatment.
How similar studies have performed: While corticosteroids are the standard treatment for radionecrosis, this approach using Chlorophyllin is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Archya Dasgupta, MD — Tata Memorial Hospital
- Study coordinator: Archya Dasgupta, MD, DNB
- Email: archya1010@gmail.com
- Phone: 02224177000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.