| CTRI Number |
CTRI/2025/10/096586 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Studying Ways to Prevent Chemotherapy-Related Nausea and Vomiting in Cancer Patients at a Hospital |
|
Scientific Title of Study
|
Clinical Assessment of Preventive Strategies for Chemotherapy Induced Nausea Vomiting in Cancer Patients at a Tertiary Care Teaching Hospital: A Prospective Study |
| 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 Manjula G |
| Designation |
Assistant Professor and guide |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
KLE Academy of Higher Education and Research Nehru Nagar Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7204551475 |
| Fax |
|
| Email |
manjulag@klepharm.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula G |
| Designation |
Assistant Professor and guide |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
Room No. 14, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Karnataka, 590010.
KARNATAKA
590010
India |
| Phone |
7204551475 |
| Fax |
|
| Email |
manjulag@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Harshvardhan Patil |
| Designation |
Student |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
Room no. 14, Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Karnataka, 590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
7330141111 |
| Fax |
|
| Email |
h1737186@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sampathkumar S Shivanagi Cancer Hospital, Belagavi, 590010 |
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy, Belagavi |
| Address |
KLE College of Pharmacy, Belagavi, Karnataka, 590010. |
| Type of Sponsor |
Research institution |
|
|
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 Manjula G |
Dr. Sampathkumar S Shivanagi Cancer Hospital |
Department of Pharmacy Practice, division of medical Oncology.
Belgaum
Karnataka
Belgaum
KARNATAKA |
7204551475
manjulag@klepharm.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D49-D49||Neoplasms of unspecified behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Pharmacist Intervention |
Patient will receive Patient Information Leaflet,
Patient Education videos,
Mobile Application,
Patient Counselling during data collection until follow up at day 7,14,21. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18yrs of both the gender.
Patients with a histological / pathological confirmation of cancer diagnosis.
Patients undergoing chemotherapy.
|
|
| ExclusionCriteria |
| Details |
Vulnerable patients (pregnant women, lactating women, disabled people).
Patients who are not on chemotherapy.
Patients who are not willing to participate in research.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the effectiveness of preventive strategies for chemotherapy induced nausea vomiting.
Decreased incidence and severity of chemotherapy induced nausea and vomiting and Clinical pharmacist interventional tools to reduce CINV-related complications and improved patient quality of life. |
1 week, 2 weeks and 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/11/2025 |
| 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="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 Prospective Study, where we include patients of cancer diagnosis and undergoing chemotherapy as treatment with histological/pathological confirmation and experiencing chemotherapy-induced nausea and vomiting and exclude cancer patient who are not undergoing any chemotherapy treatment but are taking other standard treatment. In this study we aim to assess the anti-emetics used to prevent chemotherapy-induced nausea and vomiting and factors associated with increased risk of chemotherapy induced nausea and vomiting. We also aim to determine the impact of chemotherapy-induced nausea and vomiting (CINV) on the quality of life of cancer patients and to evaluate the effectiveness of clinical pharmacist–led interventions, including patient information leaflets, educational videos, mobile applications, and individualized counselling, in improving patient quality of life. |