| CTRI Number |
CTRI/2017/12/010869 [Registered on: 13/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Aprepitant and Olanzapine in the treatment of vomiting |
|
Scientific Title of Study
|
A comparative study of Aprepitant and Olanzapine in the prevention of chemotherapy induced nausea and vomiting in carcinoma of breast patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh S |
| Designation |
Assistant professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Radiotherapy,
Room no 22
KR hospital,
Irwin road
Mysore KARNATAKA 570001 India |
| Phone |
9886873788 |
| Fax |
|
| Email |
dal_muk1@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mukesh S |
| Designation |
Assistant professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Radiotherapy,
Room no 22
KR hospital,
Irwin road
KARNATAKA 570001 India |
| Phone |
9886873788 |
| Fax |
|
| Email |
dal_muk1@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Akshya |
| Designation |
Senior Resident |
| Affiliation |
Mysore medical college and research institute |
| Address |
Department of Pharmacology
Mysore medical college
Irwin road
Mysore Department of Radiotherapy,
Room no 22
KR hospital,
Irwin road Mysore KARNATAKA 570001 India |
| Phone |
9739097923 |
| Fax |
|
| Email |
j.k_akshay@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical college and research institute
Department of Radiotherapy
Room no 22
KR hospital
Mysore 570001
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Mysore medical college ad research institute |
| Address |
Department of Radiotherapy,
Room no 22
KR hospital,
Irwin road |
| 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 Mukesh S |
Mysore medical collehe and research institute |
Department of Radiotherapy,
Room no 22
KR hospital,
Irwin road Mysore KARNATAKA |
9886873788
dal_muk1@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast cancer , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Aprepitant 125mg per orally on day 1 and Tablet Aprepitant 80mg on day 2 and day 3 |
This drug is given from the day of chemotherapy up to day 3 in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 |
| Intervention |
Tablet Olanzapine 10mg per orally day 1 to 3 |
This drug is given from the day of chemotherapy up to day 3 in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically confirmed breast cancer.
2. Chemotherapy naive patients.
3. Not complaining of nausea in the past 24
hours prior to initiation of chemotherapy.
4. Renal and liver function tests of the
patients within the normal range
5. Patients with child bearing potential had to
have a negative urine pregnancy test
|
|
| ExclusionCriteria |
| Details |
1. History of seizure disorder
2. Brain Metastasis
3. Treatment with another antipsychotic agent
such as risperidone, quetiapine, clozapine,
phenothiazine or butyrophenone for 30 days
prior to or during protocol therapy.
4. Hypersensitivity to olanzapine
5. History of cardiac arrhythmia
6. Uncontrolled congestive cardiac failure or
acute myocardial infarction in the previous
6 months
7. History of diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of Aprepitant and Olanzapine in the prevention of Chemotherapy Induced Nausea. |
Day 1 to day 5 from the start of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of Aprepitant and Olanzapine in the prevention of acute and delayed emesis |
Day 1 to day 5 from the start of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="122" Sample Size from India="122"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1.Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472-78
2.Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008;358(23):2482-94 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chemotherapy
Induced Nausea and Vomiting (CINV) the most common side effect of chemotherapy is associated with a significant deterioration in quality of life and is perceived by patients as a major adverse effect of treatment.
Chemotherapy
is a common modality for treatment of Carcinoma Breast. Regardless of the fact
that chemotherapy improves survival, it has its own toxicity and side effects
of which nausea and vomiting being significant can affect patient compliance.
To avoid the clinical sequelae of CINV like dehydration, electrolyte imbalance,
malnutrition, anorexia, stress and anxiety, it is imperative to provide
prophylaxis and treatment for CINV.
The principal
neurotransmitters that drive CINV in all forms are serotonin, dopamine,
acetylcholine, and substance P. The use of 5-hydroxytryptamine3
(5-HT3) receptor antagonist plus dexamethasone has significantly improved
the control of acute CINV. Recent studies have demonstrated
additional improvement in the control of acute CINV and delayed CINV with the
use of newer agents: Palonosetron, a second generation 5-HT3 receptor
antagonist. Aprepitant, the first agent available in the drug
class of neurokinin-1 (NK1)-receptor antagonists and
Olanzapine, an antipsychotic which is used in the treatment of psychotic
symptom, blocks multiple neurotransmitters in the central nervous
system. These newer drugs incorporated in prophylactic regimens
for CINV have resulted in significantly reduced rates of this feared complication
of cytotoxic chemotherapy. A recent randomized trial evidence has suggested
that Olanzapine may have a role in both the prevention and treatment of CINV. |