Study to assess the effect of oral resveratrol and copper combination on life span of glioblastoma patients undergoing surgery .
Phase 1
- Conditions
- Health Condition 1: G938- Other specified disorders of brain
- Registration Number
- CTRI/2020/10/028476
- Lead Sponsor
- Tata Memorial Centre TMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Radiologic suspicion of GBM on MRI brain (As per discussion in the Tumor Board meetings)
2.Adults - Age above 18 years
3. KPS > 70
4.Planned for Debulking Surgery and adjuvant treatment at Tata memorial centre
5.Adequate hepatic, renal, and hematologic function at baseline
6.Patients who have given written informed consent
Exclusion Criteria
Multifocal disease / disease not amenable to complete resection
2.Any prior treatment for cancer â?? surgery, chemotherapy or radiotherapy
3.Past history of cancer
4.Uncontrolled medical comorbidities like hypertensive, diabetes mellitus
5.Seropositivity: HbsAg, HCV, HIV positive, etc.
6.Presence of metastases
7.Patients taking alternative/ complementary treatments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate changes in OS at 2 years in GBM patients who receive oral R-Cu therapy during the peri-operative treatment phase.Timepoint: 2 years
- Secondary Outcome Measures
Name Time Method 1.To evaluate changes in PFS in GBM patients who receive R-Cu therapy during the peri-operative treatment phase. <br/ ><br>2.To evaluate if peri-operative R-cu therapy will down-regulate cancer hallmarks <br/ ><br> <br/ ><br>Timepoint: 1 YEAR