| CTRI Number |
CTRI/2024/10/075129 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of Prescription Patterns and Drug Interactions in Cancer Patient |
|
Scientific Title of Study
|
Assessment of Medication Use Pattern and Drug-Drug Interactions among Prostate Cancer Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshatha S |
| Designation |
Student |
| Affiliation |
NGSM Institute Of Pharmaceutical Sciences |
| Address |
Dept.Of Pharmacy Practice, NGSM Instiitute Of Pharmaceutical Sciences, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7736564785 |
| Fax |
|
| Email |
akshathasachu.2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute Of Pharmaceutical Sciences |
| Address |
Dept. Of Pharmacy Practice, NGSM Institute Of Pharmaceutical Sciences, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Dept. Of Pharmacy Practice, NGSM Institute of Pharmaeutical Sciences, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE(Deemed to be University) Deralakkatte, Mangalore, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE( Deemed to be University), NGSM Institute of Pharmaceutical Sciences. |
| Address |
Deralakatte, Mangalore, 575018 |
| Type of Sponsor |
Other [Educational 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 Vijith Shetty |
Justice K S Hegde Charitable Hospital |
Dept. of Medical Oncology, Ground Floor and Dept. Of Urology, Third floor
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
8861796017
drvijithshetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute Of Pharmaceutical Sciences Institutional Ethics Committee(NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
1. All the prostate cancer participants aged 18 & above.
2. Prostate cancer participants with or without comorbidities.
3. Prostate Cancer patients diagnosed with other types of cancer. |
|
| ExclusionCriteria |
| Details |
1. Patients who had undergone surgical ADT.
2. Patients with incomplete data files.
3. Patients who are not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will identify the common drug use pattern among prostate cancer patients |
zero |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will identify the potential drug-drug interactions among prostate cancer patients. |
one year |
|
|
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)
|
21/10/2024 |
| 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="0"
Months="6"
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
|
INTRODUCTION Prostate cancer is a common malignancy affecting the prostate gland in men, particularly those over 65. In 2022, prostate cancer accounted for about 1.5 million new cases and 397,000 deaths globally, making it the second most common cancer in men. Managing prostate cancer often involves complex treatment regimens, which increase the risk of drug-drug interactions (DDIs), potentially leading to reduced drug efficacy or increased toxicity. Understanding and managing these interactions is crucial for patient safety and treatment success. OBJECTIVES The study aims to investigate the medication use patterns using the WHO core prescribing indicators and to identify the potential drug-drug interactions in prostate cancer. METHODOLOGY This ambispective study will be conducted at the Department of Urology and Oncology, Justice KS Hegde Charitable Hospital in Deralakatte, Mangalore. The sample size is calculated to be approximately 150 participants. The study will span six months, from September 2024 to February 2025, and include all the Prostate Cancer patients treated last 2 years and all the in-patients and out-patients in the Urology and Oncology department, with certain exclusion such as patients who had undergone surgery ADT. STATISTICAL ANALYSIS Continuous data will be expressed as Mean ± SD. Categorical data will be expressed in frequency percentages. Data analysis will be carried out using SPSS software version 29. ANTICIPATED OUTCOME The study will identifies common drug use patterns among prostate cancer patients and it emphasizes the importance of identifying and categorizing potential drug-drug interactions (DDIs) to optimize treatment and ensure patient safety. The goal is to manage DDIs effectively, improve patient outcomes, and enhance the quality of care. |