| CTRI Number |
CTRI/2025/03/081899 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Using Cannabis (Medical bhang) During and After Pancreatic Cancer Surgery: Can It Help Patients Live Longer? |
|
Scientific Title of Study
|
Peri-operative cannabis use in patients undergoing pancreaticoduodenectomy for pancreatic and periampullary carcinoma- A phase II,III open label randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 4244_3.0dated 26 Oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1102 11th Floor Homibhabha building Tata Memorial Hospital
Dr E Borges Marg Parel
Mumbai INDIA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1102 11th Floor Homibhabha building Tata Memorial Hospital
Dr E Borges Marg Parel
Mumbai INDIA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1102 11th Floor Homibhabha building Tata Memorial Hospital
Dr E Borges Marg Parel
Mumbai INDIA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure support
Tata memorial hospital dr ernest borges marg parel mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr E Borges Marg Parel
Mumbai
MAHARASHTRA
400012
India |
| 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 Manish Bhandre |
Tata Memorial Hospital |
OPD No 324, 3rd Floor, Homi Bhabha Building, Dr E borges Road, Parel
Mumbai
MAHARASHTRA |
7738389116
manishbhandare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cannabis Sativa CBD or THC |
Patient will be admitted for surgery and the Cap THC or CBD (7.5mg CBD and 7.5 mg THC) once a day starting 4 days before surgery and total of 5 doses will be given pre-surgery, the last dose being on the day of surgery
Additionaly, Cap THC or CBD (2.5mg CBD and 2.5 mg THC per 100 mg ) will be given three times a day along with adjuvant chemotherapy from one day prior to start of chemotherapy and continued daily till 4 days after completion of the chemotherapy cycle during all cycles. |
| Comparator Agent |
Standard of care |
The control arm shall receive standard of care alone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Treatment naïve patients with radiologically suspected or histopathologically proven pancreatic cancer and periampullary carcinoma, undergoing curative intent treatment.
2.Age more than 18 and less 65
3.Valid informed consent
5.Non-metastatic
6.Undergoing curative surgery for operable pancreatic cancer and periampullary carcinoma(T1 to T3, N0 to N1, M0)
|
|
| ExclusionCriteria |
| Details |
1. Undergoing any other pre or peri-operative intervention such as neoadjuvant chemotherapy or radiotherapy
2. Presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, gastro-intestinal disease which will interfere with any study specific procedure
3. Presence of uncontrolled cardiovascular disease, controlled hypertensives or diabetics will be allowed
4. History of substance abuse (including cannabis-related products) or alcohol abuse
5. Personal history of psychiatric disease
6. Significant family history of psychiatric disease
7. Pregnancy and or lactation.
8. Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
9. 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
10. Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study.
11.Any patient with positive HIV, HBsAg, HCV status
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Disease-free survival (DFS) with perioperative cannabis as compared to standard treatment in patients undergoing pancreaticoduodenectomy for pancreatic cancer and periampullary carcinoma |
Disease free survival upto 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 5 years Overall Survival(OS) |
5 years from the date of randomisation |
| To evaluate the safety and tolerability of preoperative cannabis. |
2 hours, 4 hours, 6 hours, 12 hours and 24 hours after study drug administration |
| To assess the pathological response to preoperative cannabis. |
Immediately after surgery |
| To study the pharmacokinetics and pharmacodynamics of cannabis |
Blood collection will be done once pre-dose 30 mins, 1 hour, 2 hours, 4 hours and 8 hours post-dose. |
|
|
Target Sample Size
|
Total Sample Size="751"
Sample Size from India="751"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="10"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized controlled study to assess the effect of cannabis administered at safe medical dose on survival in patients undergoing pancreaticoduodenectomy for pancreatic and periampullary carcinoma. We will be administering cannabis formulation (Cap THC or CBD, 7.5mg CBD and 7.5 mg THC per 100 mg) once a day starting from 4 days before surgery. A total of 5 pre-operative doses will be given with 5th dose being on the day of surgery. After that we will be administering Cap THC or CBD (2.5mg CBD and 2.5 mg THC per 100 mg )three times a day along with adjuvant chemotherapy from one day prior to start of chemotherapy and continued daily till 4 days after completion of the chemotherapy cycle during all cycles. This study is a open label randomized, controlled prospective phase II/III clinical trial. Participants who are getting enrolled will be randomly distributed to either of the two groups. One group will get cannabis formulation as described along with standard treatment and other group will get standard treatment only. Before participating in the study patients will undergo psychiatric assessment to assess fitness to receive cannabis formulation. Patients have to read the consent document carefully in the language they best understand before giving consent to participate in the study. Primary end point of the study is to assess the disease free survival and overall survival. The adverse effects of cannabis formulations have been explained in detail in consent form. The treatment is expected to improve overall outcome of the patient in terms of time till recurrence and overall survival. There is also a possibility that there may not be a direct benefit to the participants from this study. Advances in cancer treatment and discovery of effective drugs that are being used today are the result of clinical studies that have been done in the past. |