| CTRI Number |
CTRI/2025/02/081330 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Preventing Chemotherapy-Induced Vomiting Without Using Steroids |
|
Scientific Title of Study
|
A Prospective, Assessor-blinded, Randomized Study to Assess the Safety and Efficacy of Dexamethasone-Free Antiemetic Regimen in Patients Receiving Highly Emetogenic Chemotherapy (HEC) at Goa Medical College and Hospital |
| 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 Jivan Babulal Jain |
| Designation |
Senior Resident in department of Medical Oncology |
| Affiliation |
Goa medical college and hospital |
| Address |
Department of Medical oncology, 6th Floor, Superspeciality block, Goa Medical
college and Hospital, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
7021431906 |
| Fax |
|
| Email |
drjivanjain001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Borker |
| Designation |
Professor and Head, Department of Medical Oncology |
| Affiliation |
Goa Medical College and Hospital, Goa |
| Address |
Department of Medical oncology, 6th Floor, Superspeciality block, Goa Medical
college and Hospital, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
9869084466 |
| Fax |
|
| Email |
dranupamasb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jivan Babulal Jain |
| Designation |
Senior Resident in department of Medical Oncology |
| Affiliation |
Goa medical college and hospital |
| Address |
Department of Medical oncology, 6th Floor, Superspeciality block, Goa Medical
college and Hospital, Bambolim, Goa
North Goa
GOA
403202
India
North Goa
GOA
403202
India |
| Phone |
7021431906 |
| Fax |
|
| Email |
drjivanjain001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medical oncology, 6th Floor, Superspeciality block, Goa Medical college and
Hospital, Bambolim, North Goa - 403202, India |
|
|
Primary Sponsor
|
| Name |
Department of Medical Oncology, Goa Medical College, Bambolim, Goa |
| Address |
Department of Medical Oncology, Goa Medical College, Bambolim, Goa 403202 |
| 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 Jivan Babulal Jain |
Goa medical college and hospital |
Department of Medical oncology,
6th Floor, Superspeciality block,
Bambolim, Goa
North Goa
GOA
North Goa
GOA |
7021431906
drjivanjain001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, 3rd Floor, College Building, Goa Medical College, Bambolim Goa 403202 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R112||Nausea with vomiting, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
OPD arm |
Patients in the OPD arm (control arm) to receive tablet olanzapine 5 mg orally, intravenous (IV) palonosetron 0.25 mg, and IV Dexamethasone 12 mg. Tablet Olanzapine 5 mg orally once a day will be continued on days 2, 3, and 4 of chemotherapy |
| Intervention |
OPF arm |
Patients in the OPF arm (study arm) to receive tablet olanzapine 5 mg orally, IV palonosetron 0.25 mg, and IV fosaprepitant 150 mg
. Olanzapine 5 mg orally once a day will be continued on days 2, 3, and 4 of chemotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Chemotherapy naive patients, planned for 1st cycle of HEC
2) Age 18 to 99 years
3) Eastern Cooperative Oncology Group performance status less than or equal to 2
4) Absence of nausea and vomiting 24 hours before enrollment
5) Adequate organ function
6) No severe alcohol use disorder as per DSM 5 |
|
| ExclusionCriteria |
| Details |
1) Patients receiving steroids as part of a chemotherapy regimen or premedication.
2) Multiday chemotherapy
3) Patients in whom steroids are contraindicated (uncontrolled DM and HTN).
4) Patients with brain primary malignancy and brain metastasis.
5) Treatment with another antipsychotic agent for 30 days before or during the protocol |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete Response Rate (CRR) of Chemotherapy induced nausea and vomiting at 0 to 120 hours post-chemotherapy. Complete response is no emesis and no use of rescue antiemetics within the assessment period |
Acute phase: 0–24 hours post-chemotherapy
Delayed phase: 24–120 hours post-chemotherapy
Overall phase: 0–120 hours post-chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Nausea (Patient-Reported Outcomes) at 0–120 hours post-chemotherapy. Measured using a validated nausea scale |
Acute (0–24h), Delayed (24–120h), Overall (0–120h) |
| Requirement for Breakthrough Antiemetic Medications. Proportion of patients needing additional antiemetics post-chemotherapy |
0-120 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/03/2025 |
| 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="1"
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
|
Introduction: Dexamethasone (DEX), a corticosteroid, is an essential component of antiemetic regimens recommended by several guidelines, including ASCO, ESMO and Multinational Association of Supportive Care in Cancer, and the NCCN, for the prophylaxis against chemotherapy-induced nausea and vomiting (CINV) for patients receiving highlyemetogenic chemotherapy (HEC) HEC includes Anthracycline/Cyclophosphamide combination, Cisplatin, Cyclophosphamide (>1500 mg/m2), Cytarabine (1 gm/m2), Carmustine, Dacarbazine, Mechlorethamine, Streptozotocin Despite the emergence of newer antiemetic agents, such as 5-HT3 receptor antagonists, NK-1 receptor antagonists, and olanzapine, the omission of DEX from prophylaxis for patients receiving HEC has not been studied Cumulative dose of DEX over six cycles of HEC, can lead to potential toxicities such as insomnia, hyperglycemia, gastritis, emotional disturbance, hypertension, acne, increased appetite, and weight gain Unlike DEX, the NK-1 antagonists are well tolerated, no long-term toxicities have been reported
NEED FOR STUDY: Despite the availability of newer antiemetics such as 5 HT-3 and NK-1 antagonists, there are very few studies evaluating the safety and efficacy of dexamethasone (DEX)-free antiemetic regimen in patients receiving highly emetogenic chemotherapy (HEC) Given the long term serious side effects of steroid use, there is need to evaluate safety and efficacy of dexamethasone free antiemetic regimen in oncology setting AIMS AND OBJECTIVES: The primary objective of the study is to compare the complete response (CR) rates for nausea and vomiting during the acute, delayed and overall period between the OPF (Olanzapine, Palenosetron, Fosaprepitant) regimen and OPD (Olanzapine, Palenosetron, Dexamethasone) regimen in patients receiving HEC To compare Incidence of Nausea and Requirement for Breakthrough Antiemetic Medications between both groups STUDY DESIGN: A Prospective, Assessor-blinded, Randomized Study to Assess the Safety and Efficacy of Dexamethasone-Free Antiemetic Regimen in Patients Receiving Highly Emetogenic Chemotherapy (HEC) at Goa Medical College and Hospital Duration of study: 1 year INCLUSION CRITERIA: 1) Chemotherapy-naive patients, planned for 1st cycle of HEC 2) Age 18 to 99 years 3) Eastern Cooperative Oncology Group performance status <=2 4) Absence of nausea and vomiting 24 hours before enrollment 5)Adequate organ function 6) No severe alcohol use disorder as per DSM-5 Exclusion criteria: 1) Patients receiving steroids as part of a chemotherapy regimen or premedication 2) Multiday chemotherapy 3) Patients in whom steroids are contraindicated (uncontrolled DM and HTN) 4) Patients with brain primary malignancy and brain metastasis 5) Treatment with another antipsychotic agent for 30 days before or during the protocol |