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

Launched by TATA MEMORIAL CENTRE · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called chlorophyllin to see if it can help manage a condition known as radionecrosis in patients with diffuse glioma, a type of brain tumor. Radionecrosis occurs when healthy brain tissue is damaged after radiation treatment, leading to symptoms like headaches or weakness in some patients. Chlorophyllin is derived from the green pigment in plants and has various health benefits. This study aims to find out if chlorophyllin can improve the symptoms and imaging results in patients experiencing radionecrosis.

To participate in the trial, individuals must have a confirmed diagnosis of diffuse glioma and show signs of radionecrosis, either with new symptoms or without them. Patients will be monitored for three months, as the study will involve a total of 118 participants over two years. Those interested should be generally healthy enough to engage in the study and should not have certain complications or prior treatments that could interfere with the results. This research is important as it may offer a new treatment option for a challenging side effect of brain cancer therapy.

Gender

ALL

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)