Taking people in IndiaPhase 2

Tests chlorophyllin for brain damage caused by radiation treatment

Tests chlorophyllin in adults with diffuse glioma and radiation-related brain tissue damage.

Key facts

Who runs it: Tata Memorial Centre
Where: Mumbai, IndiaSee the site
Trial code: NCT06016452
Registry title: A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma
Status: Recruiting
Phase: Phase 2
People taking part: 118 people, planned
Started: 13 Nov 2023
Planned end: Nov 2025
Type of study: Interventional, 2 groups
Treatments tested: Chlorophyllin
Record updated: 11 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 70 with diffuse glioma who have brain radionecrosis seen on imaging, with or without new symptoms. It tests chlorophyllin.

Age: 18 to 70 years
Sex: All sexes can join.
Disease stage: Diffuse glioma confirmed by tissue examination, with radionecrosis (damage from radiation) seen on imaging. People with new or worse symptoms and people without new symptoms can both join.
Earlier treatment: People who had bevacizumab before cannot join.

Main reasons for not taking part

No tissue diagnosis
Karnofsky Performance Scale (KPS) below 50
Disease progression
Cannot take corticosteroids
Brainstem glioma

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

Contraindications to corticosteroids
Prior treatment with bevacizumab (either for disease progression or radionecrosis)
Disease progression
Indeterminate for radionecrosis vs disease progression
No tissue diagnosis
KPS< 50
Altered mental status with deficits in understanding or inability to consent to the study
Brainstem glioma

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

Where in India

Tata Memorial HospitalMumbai, IndiaContact: Dr Archya Dasgupta, MDTaking people

About the trial

What the trial wants to find out

Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN).

Read full original descriptionShow less

At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients.

This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis.

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, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent.

This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years.

The study is funded by Bhabha Atomic Research Centre (BARC).

The 2 groups in the trial

Stratum A (Symptomatic)Treatment being tested
Response rates at 1 month with a combination of steroids and CHL in this study is expected to be 65% as compared to the standard 50% response with the use of dexamethasone alone. For the study with an α of 0.1 and power of 80%,50 pts will be needed to achieve the desired output. In the first stage, 22 patients will be needed for assessment and continued to stage 2 if \>10 responses are seen.The stage 2 of the study will be considered successful if \>29 responses are achieved using the pre-specified response assessment criteria.Considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 60 patients will be accrued in stratum A with the purpose of achieving 50 patients with endpoints available for analysis.
Treatment: Chlorophyllin
Stratum B (Asymptomatic)Treatment being tested
This stratum includes pts without neurological worsening during imaging diagnosis of RN (asymptomatic RN).Approx 30% of patients continue to be neurologically/ radiologically stable or regression of imaging findings without need for further interventions (including corticosteroids).In the proposed study with the use of CHL, 45% patients are assumed to remain clinically and neurologically stable. With an α of 0.1 and power of 80%, 48 patients will be needed to achieve the desired outcome. In the first stage, 23 patients will be needed for assessment and continue to stage 2 if \>6 responses are seen. The phase 2 study will be considered successful if \>18 responses are achieved using the pre-specified response assessment criteria. Further considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 58 patients will be accrued in stratum B with the purpose of achieving 48 patients with endpoints available for analysis.
Treatment: Chlorophyllin