| CTRI Number |
CTRI/2026/02/103238 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Looking at Quick Side Effects of Chemotherapy Treatment Given in One Day at a Cancer Hospital |
|
Scientific Title of Study
|
Analysis of Acute Adverse Drug Reactions Occurring in Day Care Chemotherapy Setting at Tertiary Care Cancer Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopesh Soni |
| Designation |
Consultant |
| Affiliation |
Mahatma Gandhi Medical College, Jaipur, Rajasthan |
| Address |
Gopesh Soni, Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8947997300 |
| Fax |
|
| Email |
gopeshsoni1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopesh Soni |
| Designation |
Consultant |
| Affiliation |
Mahatma Gandhi Medical College, Jaipur, Rajasthan |
| Address |
Gopesh Soni, Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8947997300 |
| Fax |
|
| Email |
gopeshsoni1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopesh Soni |
| Designation |
Consultant |
| Affiliation |
Mahatma Gandhi Medical College, Jaipur, Rajasthan |
| Address |
Gopesh Soni, Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8947997300 |
| Fax |
|
| Email |
gopeshsoni1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gopesh Soni |
| Address |
Second Floor, Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan, India 302022 |
| Type of Sponsor |
Private 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 Gopesh Soni |
Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan (302022) |
Second floor, Pharmacology Department, Mahatma Gandhi Medical College, Sitapura,
Jaipur, Rajasthan (India) – 302022
Jaipur
RAJASTHAN |
08947997300
gopeshsoni1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Hospital, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Adult (above 18 years) Patients undergoing chemotherapy in the day care setting at the tertiary care cancer centre
Patients who provide informed consent for participation in the study
|
|
| ExclusionCriteria |
| Details |
Patients receiving concurrent radiotherapy or immunotherapy in addition to chemotherapy (to avoid confounding due to overlapping toxicities).
Patients with known hypersensitivity to any of the chemotherapeutic agents before initiation of treatment.
Patients on palliative or end-of-life care, where ADR assessment may be confounded by disease progression.
Patients with pre-existing severe organ dysfunction (e.g., hepatic or renal impairment) that could independently predispose to drug toxicity.
Patients receiving investigational or unapproved drugs as part of a clinical trial during the study period.
Pregnant or lactating women, since chemotherapy safety profiles differ in this population.
Patients who leave against medical advice (LAMA) or are lost to follow-up before completion of chemotherapy cycle assessment.
Patients with incomplete medical records or missing ADR documentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the incidence of acute drug reactions among patients undergoing chemotherapy in the day care setting.
|
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the types and patterns of acute adverse drug reactions associated with different chemotherapy regimens.
To evaluate the severity of drug reactions using standard grading criteria (WHO-UMC scale)
To assess the management strategies for acute drug reactions in the
day care chemotherapy setting.
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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
|
This is a prospective observational study proposed by Gopesh Soni (Tutor, Principal Investigator) and Dr. Anusha Vohra (Professor & HOD, Co-Principal Investigator) from the Department of Pharmacology, Mahatma Gandhi Medical College & Hospital, Jaipur.
Title: “Analysis of Acute Adverse Drug Reactions Occurring in Day Care Chemotherapy Setting at Tertiary Care Cancer Centre”
Purpose: To examine sudden (acute) side effects/reactions that happen during or shortly after chemotherapy given in the day-care (outpatient/same-day) unit of a specialized cancer hospital. The study focuses on how often these reactions occur, what types they are (e.g., allergic, nausea, anaphylaxis), their severity (using tools like WHO-UMC or similar scales), which chemotherapy drugs cause them most, and how they are managed/treated on the spot.
Key details:
- Study type: Prospective observational (real-time monitoring as events happen, no intervention/experiment).
- Duration: 12 months after ethics approval.
- Location: Chemotherapy day-care ward and Pharmacology Department, MGMC&H, Jaipur.
- Participants: All consenting adult (>18 years) patients receiving chemotherapy in the day-care setting (no fixed sample size; all eligible during the period).
- Exclusions: Patients with concurrent other therapies (e.g., radiotherapy), known allergies beforehand, pregnancy, severe organ issues, clinical trial drugs, etc.
- Methods: Observe and record acute ADRs during chemo sessions, assess causality, severity, patterns by drug/regimen, and management approaches. Data analyzed using basic stats (e.g., in Excel).
- Rationale: Chemotherapy drugs often cause reactions due to their toxicity; monitoring helps improve safety, reduce under-reporting, and enhance patient care in India, where ADR reporting is low.
- Ethics aspects: Includes patient information sheet, informed consent (English & Hindi), no direct risks/benefits to participants (observational only), confidentiality via codes, voluntary participation.
- No budget/drug costs involved (routine care).
|