| CTRI Number |
CTRI/2020/03/024106 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Additional benefit of adding Canabinoid or placebo tablet to antiemtic
chemotherapeutic regimen to improvise the nausea vomiting control. |
|
Scientific Title of Study
|
A randomized, double blinded, parallel-group, phase 3 study to investigate the efficacy and
tolerability of palonosetron, dexamethasone, aprepitant plus oral cannabinoid versus
palonosetron, dexamethasone and aprepitant alone in patients receiving highly emetogenic
chemotherapeutic (HEC) regimens |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vikas ostwal |
| Designation |
Associate professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
department of medical oncologist 11th floor 1102 homibhaba block dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vikas ostwal |
| Designation |
Associate professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
department of medical oncologist 11th floor 1102 homibhaba block dr ernest borges marg parel mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vikas ostwal |
| Designation |
Associate professor and Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
department of medical oncologist 11th floor 1102 homibhaba block dr ernest borges marg parel mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hempcann Solutions Pvt Ltd, located in Bhubaneshwar, Odisha |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
dr ernest borges marg parel mumbai 400012 |
| 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 |
| vikas ostwal |
Tata Memorial Hospital |
dr ernest borges marg parel mumbai 400012
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
palonosetron, dexamethasone, aprepitant and placebo |
Day 0 (1 day before chemotherapy)
Placebo three times at 4 hourly intervals
Day 1
60 mins before chemotherapy,
capsule aprepitant 125 mg PO plus
Palonosetron 0.25mg IV plus
Dexamethasone 12 mg IV
Placebo three times at 4 hourly intervals
Day 2- Day 4
capsule aprepitant 80 mg PO plus
Oral dexamethasone 4mg PO BD
Placebo three times at 4 hourly intervals
|
| Intervention |
palonosetron, dexamethasone, aprepitant plus oral cannabinoid |
Day 0 (1 day before chemotherapy)
Cap THC/CBD three times at 4 hourly intervals
Day 1
60 mins before chemotherapy,
capsule aprepitant 125 mg PO plus
Palonosetron 0.25mg IV plus
Dexamethasone 12 mg IV
Cap THC/CBDthree times at 4 hourly intervals
Day 2- Day 4
capsule aprepitant 80 mg PO plus
Oral dexamethasone 4mg PO BD
Cap THC/CBD three times at 4 hourly intervals
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients has a confirmed diagnosis of cancer and is receiving one of the mentioned chemo-therapy protocols mentioned previously.
2)The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
-The patient is aged > 18 years.
a) Patients should be chemotherapy naive
b)The patient has a WHO Performance Status of ≤ c)Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria:
3) Total neutrophils ≥ 1500/mm3 Platelets ≥ 100,000/mm3 Bilirubin ≤ 1.5 x ULN (Upper Limits of Normal)Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x ULN GFR ≥ 50 ml/min
4)The patient is able to read, understand, and complete questionnaires and daily compo-nents of the Patient Diary for each study cycle.
5) For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening.
6) Has a normal baseline ECG with QTc prolongation
|
|
| ExclusionCriteria |
| Details |
1) The patient is unable to read, understand, and complete the forms required for the study.
2) The patient is pregnant (serum pregnancy test) or lactating.
3) The patient has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication.
4) The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient.
5) The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or THC/CBD
6) The patient has received an investigational drug in the previous 6 months or is scheduled to receive any investigational drug other than fosaprepitant dimeglumine during the study period
7) The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications. Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication.
8) The patient has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs. This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics
9) Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors. This will have to be evaluated for and decision taken by PI
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of interest between the two arms of antiemetics is the complete response (CR) rates post 1st cycle of chemotherapy. This is the basis for statistical considerations as men-tioned above. |
54 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-‘No emesis rates’ between the 2 arms for cycle 1 individually
-No significant nausea rates between the 2 arms for cycle 1 individually
-QOL comparisons using FLIE questionnaire between the 2 arms
-To compare tolerance and side effects with both regimens
|
54 month |
|
|
Target Sample Size
|
Total Sample Size="644"
Sample Size from India="644"
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 3 |
|
Date of First Enrollment (India)
|
26/03/2020 |
| 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="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study rationale Chemotherapy induced nausea and vomiting (CINV) are unpleasant and worrisome side effects associated with the administration of chemotherapy. Improved control of emesis positively ,impacts quality of life in patients receiving chemotherapy. Current antiemetic regimens have markedly reduced the incidences of nausea and vomiting across chemotherapy regimens, though breakthrough CINV rates range between 10-30% across regimens. Primary Objectives: The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and oral THC/CBD (active arm) and a regimen consisting of aprepitant, palonosetron, dexamethasone, and placebo (control arm) with respect to complete response (CR); the proportion of subjects with no vomiting, no significant nausea (scored as < 5 on a scale of 1-100) and no use of rescue medications during pre-specified HEC protocols for 1 cycle of chemotherapy Hypothesis: The addition of THC/CBD to palonosetron, dexamethasone and aprepitant combination will increase the CR rates [(the proportion of subjects with no vomiting, no significant nausea (scored as < 5 on a scale of 1-100) and no use of rescue medications] during HEC regimens. Objectives 1. To compare the THC/CBD containing regimen to the control arm with respect to no emesis rates (the proportion of subjects with no vomiting, and no use of rescue medications) during HEC protocols for 1 cycle of chemotherapy 2. To compare the THC/CBD containing regimen to the control arm with respect to proportion of patients with no significant nausea (< 5 on a score of 1- 100) during pre-specified HEC protocols for 1 cycle of chemotherapy 3. to compare quality of life using FLIE questionnaire 4. To compare tolerance and side effects with both regimens
|