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Search / Trial NCT06016452

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

Launched by TATA MEMORIAL CENTRE · Aug 24, 2023

Trial Information

Current as of July 24, 2025

Recruiting

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)

About Tata Memorial Centre

Tata Memorial Centre (TMC) is a premier cancer treatment and research institution located in Mumbai, India, dedicated to providing comprehensive cancer care and advancing the field of oncology through innovative clinical research. Established in 1962, TMC is renowned for its commitment to patient-centered care, cutting-edge research, and education in cancer prevention and management. The center conducts a wide array of clinical trials aimed at improving therapeutic outcomes and enhancing the quality of life for cancer patients. With a multidisciplinary approach and a focus on collaboration, TMC strives to translate scientific discoveries into effective clinical applications, making significant contributions to global cancer research initiatives.

Locations

Mumbai, Maharashtra, India

Patients applied

0 patients applied

Trial Officials

Archya Dasgupta, MD

Principal Investigator

Tata Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported