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Use of Chlorophyllin in managing brain tumor

A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients with Diffuse Glioma - CHROME

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056166
Enrollment
118
Registered
2023-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G938- Other specified disorders of brain

Interventions

Intervention1: Chlorophyllin: Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, ant

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: No tissue diagnosis. KPS 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)

Design outcomes

Primary

MeasureTime frame
Response rates (clinical-radiological) at 1 month with the use of CHL.Timepoint: 1 month post treatment with chlorophyllin

Secondary

MeasureTime frame
Clinical-radiological response rates at 3 months Biological response rates using functional imaging (PET & MRI) Survival Analysis (Progression-Free Survival and Overall Survival) EORTC QOL C -30 and BN-20 questionnaire at baseline, 1-month, and at 3-month follow-ups NANO scale score QTWIST scoreTimepoint: at 3mnths

Countries

India

Contacts

Public ContactDr Archya Dasgupta

Tata Memorial Hospital

archya1010@gmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026