Study Protocol of a Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma (CHROME)

Study Overview

The research focuses on a treatment called Chlorophyllin (CHL) for patients suffering from brain radionecrosis due to diffuse glioma. This study shows that CHL may help reduce the negative effects of radiation therapy.

Study Details

This is a phase 2 clinical trial involving adults over 18 years old with diffuse glioma experiencing radionecrosis. Patients will be split into two groups:

  • Group A: Patients with symptoms.
  • Group B: Patients without symptoms.

All patients will take 750 mg of Chlorophyllin every morning for three months. Group A will also receive a gradually decreasing dose of dexamethasone for one month. Patients will undergo MRI and PET scans to monitor their condition.

Goals of the Study

The main goal is to see how well the treatment works after one month. Other goals include tracking responses at three months, analyzing biological changes, survival rates, and the patients’ quality of life.

Why This Treatment Matters

Radionecrosis can cause severe health problems and is usually treated with corticosteroids, which may have harmful side effects. If proven effective, Chlorophyllin offers a safe and affordable alternative for managing these conditions.

Measurable Outcomes

The study aims to set clear goals for evaluating treatment effectiveness, which can help both clinics and patients in managing brain radionecrosis.

Using AI Tools

The study suggests using AI to help track clinical outcomes efficiently. Selecting the right AI tools can enhance the management and analysis of treatment results.

Next Steps

To implement these findings, starting with a pilot project could be effective. Following that, results should be tracked to see the real-world impact of using Chlorophyllin.

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