| CTRI Number |
CTRI/2025/10/096235 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dexamethasone-free anti-emetic regimen in multi-day chemotherapy |
|
Scientific Title of Study
|
A randomized, open-label, phase III trial evaluating dexamethasone-free anti-emetic regimen versus standard dexamethasone-containing regimen in patients receiving multi-day highly emetogenic chemotherapy (DEXA-FREE). |
| Trial Acronym |
Anti Emetic regimen , multi day ,chemo |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Joshi |
| Designation |
Professor |
| Affiliation |
ACTREC,TMC |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre ACTREC
Sector 22, Near Owe camp.
Kharghar Navi Mumbai. Mumbai MAHARASHTRA 410210 India |
| Phone |
09769331525 |
| Fax |
|
| Email |
dramitjoshi74@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Joshi |
| Designation |
Professor |
| Affiliation |
ACTREC,TMC |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre ACTREC
Sector 22, Near Owe camp.
Kharghar Navi Mumbai. Mumbai MAHARASHTRA 410210 India |
| Phone |
09769331525 |
| Fax |
|
| Email |
dramitjoshi74@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amit Joshi |
| Designation |
Professor |
| Affiliation |
ACTREC,TMC |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre ACTREC
Sector 22, Near Owe camp.
Kharghar Navi Mumbai. Mumbai MAHARASHTRA 410210 India |
| Phone |
09769331525 |
| Fax |
|
| Email |
dramitjoshi74@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACTREC, TMC Tata Memorial Centre ACTREC
Sector 22, Near Owe camp Kharghar Navi Mumbai
Raigad Maharashtra - 410210 India
|
|
|
Primary Sponsor
|
| Name |
ACTREC, TMC |
| Address |
Tata Memorial Centre ACTREC
Sector 22, Near Owe camp Kharghar Navi Mumbai
Raigad Maharashtra - 410210 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 Amit Joshi |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre. |
ACTREC shanti Sadan OPD no. 203, 2nd floor
Sector 22, Near Owe camp.
Kharghar Navi Mumbai. Mumbai MAHARASHTRA |
09769331525
dramitjoshi74@gmail.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 |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (Standard Regimen with DEXA):
- Dexamethasone
- Olanzapine
- 5-HT3 receptor antagonist
Palonosetron
Ondansetron
Granisetron
- NK-1 receptor antagonist
Fosaprepitant |
Control Group (Standard Regimen with DEXA):
- Dexamethasone: 12 mg IV/PO on day 1; 8 mg PO on day 2-4.
- Olanzapine: 10 mg orally daily on days 1-4.
- 5-HT3 receptor antagonist:
Palonosetron: 0.25 mg IV on day 1 and day 4 or
Ondansetron: 8 mg IV on day 1 to day 3 (in 3-day chemotherapy) or day 5 (in 5-day chemotherapy) or
Granisetron: 1 mg IV on day 1 to day 3 (in 3-day chemotherapy) or day 5 (in 5-day chemotherapy)
- NK-1 receptor antagonist:
Fosaprepitant: 150 mg IV on day 1 or
Aprepitant: 125 mg PO on day 1; 80 mg PO on day 2 and day 3.
Subjects will be instructed to use the prescribed rescue antiemetics in the event that nausea and/or vomiting develop during the 192-hour observational period. After the start of chemotherapy, during the 192 hours (8 days) |
| Intervention |
Experimental Group
Experimental Group (DEXA-Free Regimen): Olanzapine: - 5-HT3 receptor antagonist: Palonosetron Ondansetron Granisetron - NK-1 receptor antagonist: Fosaprepitant |
Experimental Group (DEXA-Free Regimen): Olanzapine: 5 mg orally daily on days 1-4. - 5-HT3 receptor antagonist: Palonosetron: 0.25 mg IV on day 1 and day 4 or Ondansetron: 8 mg IV on day 1 to day 3 (in 3-day chemotherapy) or day 5 (in 5-day chemotherapy) or Granisetron: 1 mg IV on day 1 to day 3 (in 3-day chemotherapy) or day 5 (in 5-day chemotherapy) - NK-1 receptor antagonist: Fosaprepitant: 150 mg IV on day 1 or Aprepitant: 125 mg PO on day 1; 80 mg PO on day 2 and day 3.
Subjects will be instructed to use the prescribed rescue antiemetics in the event that nausea and/or vomiting develop during the 192-hour observational period. After the start of chemotherapy, during the 192 hours (8 days). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- Age 18-70 years.
- ECOG performance status 0 to 2.
- Adequate organ function.
- Solid malignant tumor
No prior chemotherapy
- Scheduled for treatment with multi-day highly emetogenic chemotherapy.
|
|
| ExclusionCriteria |
| Details |
- History of using any of the following drugs within 48 hours of enrolment: opioids, aprepitant, Fosaprepitant, 5-HT3 receptor antagonists, steroid, dopamine receptor blockers, anti-depressants or anti-psychotics.
- Contraindications to steroid use (e.g., uncontrolled diabetes, Uncontrolled hypertension.
- Symptomatic brain metastases or recent use of anti-convulsant.
- Known psychiatric illness or recent use of antipsychotics.
- Significant QTc prolongation on ECG at baseline.
- Patients with gastro-intestinal obstruction.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
complete control rate (CCR)
|
The overall phase (0-192h). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Complete response rate (CRR)
-Total control rate (TCR)
-Quality of life |
-The acute phase (0-24h)and delayed phase (24h-192h).
-the acute (0-24h), delayed (24h-192h) and overall phase (0-192h).
- Every visit |
|
|
Target Sample Size
|
Total Sample Size="176" Sample Size from India="176"
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)
|
03/11/2025 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is looking at how to better prevent nausea and vomiting in cancer patients who are getting chemotherapy over multiple days. These side effects, called chemotherapy-induced nausea and vomiting (CINV), are common and can seriously affect a patient’s comfort and quality of life. Right now, most patients are given a steroid medicine called dexamethasone along with other anti-nausea drugs. Dexamethasone is effective but can cause side effects, especially when used for several days. These side effects may include high blood sugar, sleep problems, mood changes, infections, and high blood pressure. A recent study in patients getting chemotherapy for one day showed that removing dexamethasone from the anti-nausea treatment did not reduce its effectiveness and led to fewer side effects. This new study wants to see if the same approach works for people receiving chemotherapy over multiple days. The study will compare two groups of patients: 1.One group will get the standard anti-nausea treatment (which includes dexamethasone) 2. The other group will get a steroid-free anti-nausea treatment, which includes: a. Olanzapine (used in low doses to reduce nausea), b. A 5-HT3 blocker like palonosetron, ondansetron, or granisetron, c. An NK-1 blocker like aprepitant or fosaprepitant. If the steroid-free treatment works just as well, patients could avoid the unpleasant side effects of steroids, feel better during treatment, and have an improved quality of life. The main goal is to see how well the treatments prevent vomiting during the full course of chemotherapy. Other things the researchers will check include: 1. How much nausea patients feel, 2. How safe and tolerable the treatments are, 3.How the treatments affect daily life and satisfaction, 4.Whether patients needed extra medicine for nausea. Adults between 18 and 70 years old who are about to start multi-day chemotherapy for cancer and have not received chemotherapy before. People who recently took certain medications, have uncontrolled illnesses, or have conditions like brain metastases or severe stomach problems may not be eligible. Participation is voluntary. Before joining, each patient will be fully informed about the study and asked to sign a consent form. The process will follow all ethical and regulatory guidelines to ensure the patient’s rights and safety. |