Suspended

The Impact of Nursing and Pharmacy Care Between Xeloda® and 5-Fluoruracil Regimens in the Management of Colorectal Cancer (CRC) in Hong Kong

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2011
See protocol details

Summary

Principal SponsorVivian Wing Yan Lee
Last updated: February 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

Colorectal cancer (CRC) is the second most common cause of cancer-related death in Hong Kong. The traditional chemotherapy for CRC remains on intravenous (IV) fluorouracil (5-FU) based regimens with the response rates of 10-20% and a median survival of approximately one year. 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 CRC patients. In a previous cost-minimization study conducted in Hong Kong, it was demonstrated that capecitabine was more cost-effective than 5-FU plus oxaliplatin assuming they had equal clinical efficacy. Not only is capecitabine more cost-effective, 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. In the UK, it was demonstrated that capecitabine required less pharmacy and administration time per cycle than 5-FU based IV chemotherapy. However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine comparing to traditional IV chemotherapy in CRC patients of Hong Kong.

NCT01801085
Principal SponsorVivian Wing Yan Lee
Last updated: February 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasms by SiteRectal DiseasesNeoplasmsColorectal Neoplasms

Criteria

2 inclusion criteria required to participate
Age 18 or above

Diagnosed with CRC and prescribed with either XELOX for FOLFOX4 chemotherapy treatment

4 exclusion criteria prevent from participating
Patients less than 18 years of age

Patients who are mentally/cognitively disabled

Patients who refuse to give consent to participate

Persons related unequally to investigators

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Princess Margaret Hospital

Kowloon, Hong KongOpen Princess Margaret Hospital in Google Maps

Queen Elizabeth Hospital

Kowloon, Hong Kong
Suspended2 Study Centers