Study Protocol of a Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma (CHROME).
Archya Dasgupta, Saranga Sawant, Abhishek Chatterjee...
https://pubmed.ncbi.nlm.nih.gov/40025673Actively Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
ID06016452
A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma
Led by Tata Memorial Centre · Updated on 2025-04-11
118
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tata Memorial Centre
Lead Sponsor
B
Bhabha Atomic Research Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diffuse gliomas are common brain tumors often treated with surgery followed by radiation and chemotherapy. Radiation therapy helps target tumor cells but can also harm healthy brain tissue, causing a side effect called radionecrosis (RN). RN may appear without symptoms or cause new symptoms such as headaches, weakness, or seizures. This phase 2 study evaluates the ability of the drug Chlorophyllin to treat brain radionecrosis in patients with diffuse glioma. The study is funded by the Bhabha Atomic Research Centre and aims to assess clinical and radiological responses over two years. Participants receive Chlorophyllin, a water-soluble compound derived from chlorophyll, known for its anti-inflammatory, antioxidant, and other health properties. This study includes two groups: patients with symptomatic RN who also receive steroids, and patients with asymptomatic RN who are neurologically stable. The trial measures response rates at one month and continues follow-up for three months, with an expected enrollment of about 118 patients. Throughout the study, patients undergo clinical and radiological assessments to monitor treatment effects and safety. Researchers track response rates at one and three months, survival at three months, and health-related quality of life. The study lasts about three months per patient, with overall study duration of two years. Monitoring includes evaluating neurological status, imaging findings, and questionnaires to assess outcomes and side effects.
CONDITIONS
Brief Title
A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of diffuse glioma.
- Radionecrosis diagnosed by imaging with new neurological symptoms or worsening deficits (Stratum A) or without new symptoms (Stratum B).
- Karnofsky Performance Scale (KPS) score of 50 or higher.
- Age between 18 and 70 years.
- Ability to consent and participate in the study.
You will not qualify if you...
- No tissue diagnosis of glioma.
- Karnofsky Performance Scale (KPS) score below 50.
- Evidence of disease progression.
- Contraindications to corticosteroid use.
- Altered mental status affecting understanding or ability to consent.
- Diagnosis of brainstem glioma.
- Unclear diagnosis between radionecrosis and disease progression.
- Prior treatment with bevacizumab for disease progression or radionecrosis.
AI-Screening
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 month post treatment
Participants receive chlorophyllin to manage brain radionecrosis associated with diffuse glioma.
Regular visits during treatment period
Follow-up
Duration - 3 months
Participants are monitored for response to treatment and survival for up to 3 months after treatment.
Visits at 1 month and 3 months post treatment
Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
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Research Team
A
Archya Dasgupta, MD, DNB
T
Tejpal Gupta, MD, DNB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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