Phase 2 Study of Chlorophyllin Treatment for Brain Radionecrosis in Patients with Diffuse Glioma

What this Trial Is About

Diffuse gliomas are common brain tumors often treated with surgery followed by radiation and chemotherapy. Radiation therapy helps target tumor cells but can also harm healthy brain tissue, causing a side effect called radionecrosis RN. RN may appear without symptoms or cause new symptoms such as headaches, weakness, or seizures. This phase 2 study evaluates the ability of the drug Chlorophyllin to treat brain radionecrosis in patients with diffuse glioma. The study is funded by the Bhabha Atomic Research Centre and aims to assess clinical and radiological responses over two years. Participants receive Chlorophyllin, a water-soluble compound derived from chlorophyll, known for its anti-inflammatory, antioxidant, and other health properties. This study includes two groups patients with symptomatic RN who also receive steroids, and patients with asymptomatic RN who are neurologically stable. The trial measures response rates at one month and continues follow-up for three months, with an expected enrollment of about 118 patients. Throughout the study, patients undergo clinical and radiological assessments to monitor treatment effects and safety. Researchers track response rates at one and three months, survival at three months, and health-related quality of life. The study lasts about three months per patient, with overall study duration of two years. Monitoring includes evaluating neurological status, imaging findings, and questionnaires to assess outcomes and side effects.

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