se of Chlorophyllin in managing brain tumor
Phase 2
- Conditions
- Health Condition 1: G938- Other specified disorders of brain
- Registration Number
- CTRI/2023/08/056166
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rates (clinical-radiological) at 1 month with the use of CHL.Timepoint: 1 month post treatment with chlorophyllin
- Secondary Outcome Measures
Name Time Method Clinical-radiological response rates at 3 months <br/ ><br>Biological response rates using functional imaging (PET & MRI) <br/ ><br>Survival Analysis (Progression-Free Survival and Overall Survival) <br/ ><br>EORTC QOL C -30 and BN-20 questionnaire at baseline, 1-month, and at 3-month follow-ups <br/ ><br>NANO scale score <br/ ><br>QTWIST scoreTimepoint: at 3mnths