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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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