| CTRI Number |
CTRI/2023/03/050674 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
14/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Phase I study of Effect of Cannabis in progression of cancer |
|
Scientific Title of Study
|
Phase 1 study of safety and feasibility of Ayurvedic oral cannabis preparation and its effect
on intratumoral genetic mutation in the peri-operative period in hepatobiliary, pancreatic
cancers, breast cancers and oral squamous cell carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. 11000037 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Durgatosh Pandey |
| Designation |
Dy director |
| Affiliation |
MPMMCC HBCH Varanasi |
| Address |
OPD 1029 Mahamana Pandit Madan mohan Malaviya Cancer Centre,Sundar Bagiya, Varanasi Uttar pradesh
Homi Bhabha Cancer Hospital Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9968722018 |
| Fax |
- |
| Email |
durgatosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durgatosh Pandey |
| Designation |
Dy director |
| Affiliation |
MPMMCC HBCH Varanasi |
| Address |
OPD 1029 Mahamana Pandit Madan mohan Malaviya Cancer Centre,Sundar Bagiya, Varanasi Uttar pradesh
Homi Bhabha Cancer Hospital Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9968722018 |
| Fax |
- |
| Email |
durgatosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayanak Tripathi |
| Designation |
Associate Professor surgical oncology |
| Affiliation |
MPMMCC HBCH Varanasi |
| Address |
OPD 1045 Mahamana Pandit Madan mohan Malaviya Cancer Centre,Sundar Bagiya, Varanasi Uttar pradesh
Homi Bhabha Cancer Hospital Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8059420490 |
| Fax |
- |
| Email |
drmayanktripathi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| TRAC Tata Memorial Hospital Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E.borges Road, Parel, Mumbai, 4000012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Durgatosh Pandey |
MPMMCC |
OPD NO. 21, Ground Floor, Department of Surgical Oncology, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Varanasi
UTTAR PRADESH |
9968722018
-
durgatosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MPMMCC & HBCH, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C23||Malignant neoplasm of gallbladder. Ayurveda Condition: Cancers of gall bladder and hepatobiliary system, Oral and Breast , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: tetrahydrocannabinol (thc) and cannabidiol (cbd) , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 300(mg), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 5 Days, Reference: NA, Route: NA, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Histopathologically proven or clinic-radiologically diagnosed patients of liver, bile
duct, gall bladder and pancreatic cancers.
2. Age > 18 and < 65
3. Operable cancers planned to undergo upfront curative surgery
4. Patient fit for surgery (ASA Grade I / II)
5. Patient Voluntarily willing to give consent for study |
|
| ExclusionCriteria |
| Details |
1. Planned for any other pre or peri-operative intervention such as neoadjuvant
chemotherapy or targeted therapy or radiation
2. Presence of medical disease such as pulmonary, renal, liver, gastro-intestinal disease
which may interfere with any study specific procedure (deranged renal parameters >
1.5 times normal range or deranged liver function tests such as > 2.5 times raised liver
enzymes)
3. History of substance abuse (including cannabis-related products) or alcohol abuse
4. Personal history of psychiatric disease or Significant family history of psychiatric
disease
5. Pregnancy and/or lactation
6. Patients currently (within last 14 days before consenting) on other CNS depressants
such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
7. Patients on other medications which will likely have a drug interaction with cannabis-
such as clozapine, duloxetine, naproxen, cyclobenzaprine, olanzapine, haloperidol,
and chlorpromazine, macrolides, calcium channel blockers, benzodiazepines,
cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol,
antiretrovirals
8. Any other illness or abnormal laboratory investigations which the investigator
considers as making the patients ineligible for the study
9. Any patient with positive HIV, HBsAg, HCV status. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess maximum tolerated dose at the dose limiting toxicity in hepatobiliary and pancreatic cancer |
Day 1, day 2, day 3, day 4, day 5, before beginning the surgery , at the end of surgery, post operation day 1, post operation day 2, post operation day 3, post operation day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To establish a pharmacokinetic profile of oral cannabis preparation
2.To study the PK and SE profile for continuation into phase 2 and 3 study
3.Biomarker analysis- Effect of oral cannabis on transcriptomic profiling of the tumour
|
Day 1, day 2, day 3, day 4, day 5, before beginning the surgery , at the end of surgery, post operation day 1, post operation day 2, post operation day 3, post operation day 14. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a phase 1 trial aimed at seing effect of cannabis on tumor cells and also to calculate a safe dose of cannabis. recuriment for trial has not start at ane we planned to start recurment from 1 /OCT/ 2021. |