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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01047644
First received: January 11, 2010
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Complication of Catheter
Other: Reduced port-flush schedule
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Extended Interval Port Flushes: A Phase II Clinical Trial

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Time to port complication [ Time Frame: Every 3 months for 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Frequency and severity of toxicity [ Time Frame: every three months ] [ Designated as safety issue: Yes ]
    Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.

  • Cost effectiveness [ Time Frame: every three months ] [ Designated as safety issue: No ]
    Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.


Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3-month flushing schedule
3-month port-flushing schedule
Other: Reduced port-flush schedule
3-month port-flushing

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047644

Contacts
Contact: Goetz H Kloecker, MD 502-562-4370 ghkloe01@louisville.edu
Contact: Karen M Carter, BA, BSN 502-562-3429

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Goetz H Kloecker, MD    502-562-3429      
Contact: Karen M Carter, BA, BSN    502-562-3429      
Principal Investigator: Goetz H Kloecker, MD         
Sub-Investigator: Dharamvir Jain, MD         
Sub-Investigator: Vivek R Sharma, MD         
Sub-Investigator: Elizabeth C Riley, MD         
Sub-Investigator: Donald M Miller, MD, PhD         
Sub-Investigator: Jason A Chesney, MD, PhD         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center, University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01047644     History of Changes
Other Study ID Numbers: 09.0036
Study First Received: January 11, 2010
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
port
catheter
infusion
flush
cleanse
chemotherapy

ClinicalTrials.gov processed this record on November 20, 2014