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临床试验/CTRI/2024/10/075129
CTRI/2024/10/075129
尚未招募
不适用

Assessment of Medication Use Pattern and Drug-Drug Interactions among Prostate Cancer Patients.

NITTE( Deemed to be University), NGSM Institute of Pharmaceutical Sciences.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月21日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
NITTE( Deemed to be University), NGSM Institute of Pharmaceutical Sciences.
入组人数
150
试验地点
1
主要终点
The study will identify the common drug use pattern among prostate cancer patients

概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
Male

入选标准

  • All the prostate cancer participants aged 18 & above.
  • Prostate cancer participants with or without comorbidities.
  • Prostate Cancer patients diagnosed with other types of cancer.

排除标准

  • Patients who had undergone surgical ADT.
  • Patients with incomplete data files.
  • Patients who are not willing to give consent.

结局指标

主要结局

The study will identify the common drug use pattern among prostate cancer patients

时间窗: zero

次要结局

  • The study will identify the potential drug-drug interactions among prostate cancer patients.(one year)

研究者

发起方
NITTE( Deemed to be University), NGSM Institute of Pharmaceutical Sciences.
申办方类型
Other [Educational Institution]
责任方
Principal Investigator
主要研究者

Akshatha S

NGSM Institute Of Pharmaceutical Sciences

研究点 (1)

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