Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

February 1, 2017 updated by: Vivian Wing Yan Lee

The Impact of Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens in the Management of Advanced Esophago-gastric Cancer in Hong Kong

The objective of this study is to compare the possible time savings from reduction of nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus traditional intravenous chemotherapy in the Hong Kong public hospital setting.

Study Overview

Status

Withdrawn

Conditions

Gastric Cancer

Detailed Description

Advanced esophageal and gastric cancer (AEGC) have ranked in the top 10 cancer-related cause of death worldwide, with approximately one million new cases each year. Over half of new cases are in East Asia. The traditional chemotherapy for AEGC remains on intravenous (IV) fluorouracil (5-FU), cisplatin, and the anthracyclines. Trials favoured the combined use of 5-FU and cisplatin for superior efficacy and quality of life in AEGC patients. Recent years, oral chemotherapy has a more practical and economic advantages over IV regimen. It is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. Oral treatment strategy preserves quality of life for AEGC patients. In addition, it may also have additional cost saving in the nursing and pharmacy time. It is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of IV chemotherapy However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine-based regimen comparing to traditional IV chemotherapy in MCRC patients of Hong Kong.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients who were diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4-based chemotherapy treatment

Description

Inclusion Criteria:

Aged 18 or above
Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment

Exclusion Criteria:

Persons < 18 years of age;
Pregnant or lactating women;
Persons related unequally to investigators (e.g. student, employee);
Special population (e.g. prisoner, mentally, congnitively disabled);
Patients who refused to sign consent or not willing to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
XELOX Capecitabine (Xeloda) 1000mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130mg/m2 iv over 2 hrs d1 Q3w x 8 cycles
XP Cisplatin (CDDP) 80 mg/m2 iv over 3 hrs d1 Capecitabine (Xeloda) 1000 mg/m2 po bid d1-14, Q3w
FOLFOX Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and d2 5-FU 400mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d1 and d2 Q2w
FP Cisplatin (CDDP) 100 mg/m2 iv d1 5-FU 1000 mg/m2/d civi d1-5, Q4w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite preparation, dispensing, and administration time Time Frame: Up to 6 months after initiation of chemotherapy	This is a time-and-motion study conducted in 2 public hospitals of Hong Kong based on the simulation of previously data on both capecitabine-based regimen (XELOX and XP) and IV 5-FU-based regimen (FOLFOX and FP)	Up to 6 months after initiation of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivian Wing Yan Lee

Collaborators

Hoffmann-La Roche

Queen Elizabeth Hospital, Hong Kong

Princess Margaret Hospital, Hong Kong

Investigators

Principal Investigator: Vivian WY Lee, PharmD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria