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Extended Interval Port Flushes: A Phase II Clinical Trial


Phase 2
18 Years
85 Years
Open (Enrolling)
Both
Complication of Catheter

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Trial Information

Extended Interval Port Flushes: A Phase II Clinical Trial


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Time to port complication

Outcome Description:

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.

Outcome Time Frame:

Every 3 months for 1 year

Safety Issue:

Yes

Principal Investigator

Goetz H Kloecker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center, University of Louisville

Authority:

United States: Institutional Review Board

Study ID:

09.0036

NCT ID:

NCT01047644

Start Date:

March 2009

Completion Date:

March 2014

Related Keywords:

  • Complication of Catheter
  • port
  • catheter
  • infusion
  • flush
  • cleanse
  • chemotherapy

Name

Location
James Graham Brown Cancer Center Louisville, Kentucky  40202