Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.

Phase 2

Completed

• Conditions: Complication of Catheter
• Interventions: Other: Reduced port-flush schedule

• Registration Number: NCT01047644
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.

It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.

Detailed Description

This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.

Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1. All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
2. Without active disease
3. Able to give informed consent

Exclusion Criteria

1. Minors, prisoners
2. Previous PAC failure
3. Disease recurrence
4. Patients who had their PAC removed immediately following therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3-month flushing schedule	Reduced port-flush schedule	3-month port-flushing schedule

Primary Outcome Measures

Name	Time	Method
Time to port complication	Every 3 months for 1 year	The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months.

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of toxicity	every three months	Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.
Cost effectiveness	every three months	Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States