| CTRI Number |
CTRI/2024/04/066232 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare benefits of Olanzapine 5mg over Olanzapine 10mg for prevention of nausea and vomiting caused by anticancer medicines. |
|
Scientific Title of Study
|
A Randomized, Open Label Trial to Compare Efficacy and Safety of Olanzapine 10mgand 5mg for the prophylaxis of emesis in patients receiving highly emetogenic cancer chemotherapy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Pratap Singh |
| Designation |
PG JR |
| Affiliation |
UPUMS, Saifai |
| Address |
Pharmacology deptt.,2nd floor, Academic block, UPUMS Saifai, Etawah
Room no 37, Radiotherapy deptt., Old hospital building, UPUMS Saifai.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7302726060 |
| Fax |
|
| Email |
abhaypratapsingh108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Dixit |
| Designation |
(Proff. and Head) Department of Pharmacology |
| Affiliation |
UPUMS, Saifai |
| Address |
Pharmacology deptt.,2nd floor, Academic block, UPUMS Saifai, Etawah
Type 5, New campus, UPUMS Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9639523852 |
| Fax |
|
| Email |
alkdxt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Pratap Singh |
| Designation |
PG JR |
| Affiliation |
UPUMS, Saifai |
| Address |
Pharmacology deptt.,2nd floor, Academic block, UPUMS Saifai, Etawah
Room no 37, Radiotherapy deptt., Old hospital building, UPUMS Saifai.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7302726060 |
| Fax |
|
| Email |
abhaypratapsingh108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah , Pin-206130 |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology and Department of RadioOncology |
| Address |
Department of Pharmacology ,2nd floor, Academic block, and Department of Radio-Oncology, ground floor old OPD block, Uttar Pradesh University of Medical Sciences Saifai, Etawah-206130 |
| Type of Sponsor |
Government medical college |
|
|
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 Abhay Pratap Singh |
Uttar Pradesh University of medical Sciences, |
radiotherapy and surgical oncology department, Room no 37,old hospital building, UPUMS Saifai, Etawah
Etawah
UTTAR PRADESH |
7302726060
abhaypratapsingh108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Olanzapine 10mg |
1st day of anticancer chemotherapy- Tablet Olanzapine 10mg Once a day before chemo administration and regimen (Injection palonosetron 0.25mg once a day, Injection dexamethasone 12mg once a day),
2nd,3rd and 4th day- Tablet Olanzapine 10 mg OD and regimen( Tablet palonosetron0.25mg OD, Tablet Dexamethasone 4 mg BD)
Duration is 4 days during Chemotherapy administration |
| Intervention |
Tablet Olanzapine 5mg |
1st day of anticancer chemotherapy- Tablet Olanzapine 5mg Once a day before chemo administration and regimen (Injection palonosetron 0.25mg once a day, Injection dexamethasone 12mg once a day),
2nd,3rd and 4th day- Tablet Olanzapine 5 mg OD and regimen( Tablet palonosetron0.25mg OD, Tablet Dexamethasone 4 mg BD)
Duration is 4 days during Chemotherapy administration
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1-18 years of age or older patients who had not received previous chemotherapy
2-Patients going to receive 1st cycle of highly emetogenic cancer chemotherapy
3-Written informed consent.
4-Able to understand and describe patient-reported outcomes.
|
|
| ExclusionCriteria |
| Details |
1-History of hypersensitivity or allergy to any of antiemetic drugs we are going to use in study
2-Received any chemotherapy in last 3 weeks.
3-Multiday chemotherapy regimen, concurrent radiotherapy
4-brain metastasis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome- complete response of vomiting in early(0- 24hrs), delayed(24-120 hrs) in both groups
Secondary outcome- to record different grades of chemotherapy induced nausea and vomiting in all three periods |
early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To record different grades of chemotherapy induced nausea and vomiting (CINV) in all three periods: - Acute (0- 24 hrs), Delayed (24 -120hrs), overall(0-120hrs). |
early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs) |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study lies in its specific focus on comparing the efficacy and safety of two different doses of olanzapine (10mg and 5mg) for the prophylaxis of emesis in patients receiving highly emetogenic cancer chemotherapy. Olanzapine 10mg (control arm) as well as 5mg (test arm) have shown efficacious role in the prophylaxis of CINV while used in combination with other antiemetic drugs (Palonosetron, Dexamethasone etc.) due to its action on multiple receptors involved in emesis (D1, D2, D3, and D4, 5-HT2a, 5-HT2c, 5-HT3, and 5-HT6 receptors). While olanzapine has been shown to be an effective antiemetic agent, there is currently limited research comparing different dosages of the medication for this specific indication. As such, this study aims to provide valuable insight into whether a higher dose of olanzapine provides greater prophylaxis against emesis than a lower dose, and to identify any potential safety concerns associated with each dosage level. By filling this gap in the literature, this study has the potential to inform clinical practice and improve the management of emesis in patients receiving highly emetogenic cancer chemotherapy. |