Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

Withdrawn

• Conditions: Gastric Cancer

• Registration Number: NCT02063412
• Lead Sponsor: Vivian Wing Yan Lee

Brief Summary

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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite preparation, dispensing, and administration time	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)