Using Chlorophyllin to Treat Brain Damage from Radiation in Glioma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.