| CTRI Number |
CTRI/2020/10/028476 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
25/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess the effect of oral resveratrol and copper combination on life span of glioblastoma patients undergoing surgery . |
|
Scientific Title of Study
|
A prospective study to assess the effect ofperi operative administration of oral Resveratrol andcopper(R- Cu) on survival inGlioblastoma (GBM) patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC PROJECT NO 3456 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aliasgar V Moiyadi |
| Designation |
Prof and Consultant Neurosurgeon |
| Affiliation |
Tata Memorial Centre TMC |
| Address |
TATA MEMORIAL HOSPITAL Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177279 |
| Fax |
|
| Email |
aliasgar.moiyadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aliasgar V Moiyadi |
| Designation |
Prof & Consultant Neurosurgeon, Chief of Neurosurgery |
| Affiliation |
Tata Memorial Centre TMC |
| Address |
TATA MEMORIAL HOSPITAL Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177279 |
| Fax |
|
| Email |
aliasgar.moiyadi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aliasgar V Moiyadi |
| Designation |
Prof & Consultant Neurosurgeon, Chief of Neurosurgery |
| Affiliation |
Tata Memorial Centre TMC |
| Address |
TATA MEMORIAL HOSPITAL Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177279 |
| Fax |
|
| Email |
aliasgar.moiyadi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
TMC -Research Administration Council
Dr. E Borges Road, Parel, Mumbai - 400 012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre TMC |
| Address |
TATA MEMORIAL HOSPITAL Dr E Borges Road Parel Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ALIASGAR MOIYADI |
TATA MEMORIAL HOSPITAL |
Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA |
9324696948
aliasgar.moiyadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resveratrol-Copper |
R-Cu therapy will be administered four times a day. It will be started atleast 10 days before the surgery and will be given for12 days after the surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Multifocal disease / disease not amenable to complete resection
2. Any prior treatment for cancer – 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in OS at 2 years in GBM patients who receive oral R-Cu therapy during the peri-operative treatment phase. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate changes in PFS in GBM patients who receive R-Cu therapy during the peri-operative treatment phase.
2. To evaluate if peri-operative R-cu therapy will down-regulate cancer hallmarks
|
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
09/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glioblastoma(GBM) is a very aggressive brain tumor (and one of the commonest). Survival in Glioblastoma patients has remained poor and unchanged for over a decade. Multiple adjuvant treatment modalities have been tried but have provided meagre improvements. Resveratrol and copper (R-Cu) given in combination an degrade cell free chromatin (released from dying cancer cells and responsible for oncogenic transformation of the tumor cells). In preliminary studies,It has been found to reduce toxicity due to chemotherapy and even improve tumor outcomes. Both R and Cu are otherwise approved and wisely used nutritional supplements.Alone and in combination (in earlier studies) this has not shown to have any significant toxicities.We would like to test the efficacy of this combination of treatment in Glioblastoma patients undergoing surgery. All enrolled and consented patients will be administered R-Cu tablets for times daily for at least 10 days before the surgery and 12 days after the surgery.Additionally,they will receive routine adjuvant treatment (radiotherapy and chemotherapy) after the surgery. Patient will be followed up with routine 6 monthly MRIs for at least 2 years. Tumor tissue obtained from the first ten patients will be used for estimation of cancer hall marks,antioxidant enzymes estimation and transcriptome sequencing.Data obtained will be used to compare the overall survival and progression free survival among The R-Cu therapy group and the current prevailing literature. We expect the R-Cu therapy to improve survival by 50% overall.To assess this we plan to enroll 66 patients on the study. |