| CTRI Number |
CTRI/2026/02/104005 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of prophylactic medicine on opioid induced nausea and vomiting in adult cancer patients initiated on oral morphine |
|
Scientific Title of Study
|
Efficacy of Prophylactic Dexamethasone in Preventing Opioid-Induced Nausea and Vomiting in Cancer Patients: A Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Mishra |
| Designation |
Head of the Department, Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 249, 2nd Floor, Dr. BRA IRCH, AIIMS, New Delhi, South Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
09899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Mishra |
| Designation |
Head of the Department, Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 249, 2nd Floor, Dr. BRA IRCH, AIIMS, New Delhi, South Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
09899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Mishra |
| Designation |
Head of the Department, Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 249, 2nd Floor, Dr. BRA IRCH, AIIMS, New Delhi, South Delhi, 110029, India
South
DELHI
110029
India |
| Phone |
09899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Seema Mishra |
AIIMS |
AIIMS Palliative Medicine OPD, Dr BRA IRCH, AIIMS New Delhi
South
DELHI |
09899061105
seemamishra2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
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 (No prophylaxis) |
No antiemetic given before or with the first dose of morphine. Rescue antiemetics allowed based on need. |
| Intervention |
Intervention Group (Dexamethasone) |
8 mg oral dexamethasone once daily for 3 days, starting 4 hours before first dose of morphine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2. Diagnosed cancer (any histology)
3. Opioid-naïve, planned for oral morphine
4. Expected to take oral morphine for at least 5 days
5. Able to understand symptom reporting and provide consent
|
|
| ExclusionCriteria |
| Details |
1. Current or recent corticosteroid therapy
2. Concurrent antiemetics initiated prophylactically
3. History of steroid allergy or contraindication
4. Cognitive impairment or inability to communicate
5. Uncontrolled diabetes mellitus
6. Inability to follow up for 5 day |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nausea severity score measured using a 0–10 Numerical Rating Scale |
Day 1, Day 3, and Day 5 after initiation of oral morphine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of vomiting episodes Rescue antiemetic use
Emergency visits due to opioid-induced nausea & vomiting. |
Day 1, Day 3, Day 5 after opiod initiation |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
31/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Opioid-induced nausea and vomiting (OINV) remains a significant barrier to effective pain control in cancer patients. Despite the availability of antiemetics, prophylactic use is not routinely practiced for morphine-induced nausea. This trial evaluates the efficacy of oral dexamethasone in reducing OINV in opioid-naïve adult cancer patients. If proven effective, dexamethasone could become a simple, cost-effective, and scalable intervention in supportive oncology. |