Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00607880

Purpose

RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use.

PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Vascular Access Device Complications	Drug: chemotherapy Procedure: adjuvant therapy Procedure: catheter management Procedure: vascular access device placement

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind
Official Title:	A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Port malfunction due to partial or total occlusion at 6 and 12 months after port insertion [ Designated as safety issue: Yes ]
Port infection at 6 and 12 months after port insertion [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Central vein thrombosis at 6 and 12 months after port insertion [ Designated as safety issue: Yes ]
Death from all causes [ Designated as safety issue: Yes ]
Port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion [ Designated as safety issue: No ]
Termination of use of the indwelling port at 6 and 12 months after port insertion [ Designated as safety issue: No ]
Calculation of direct costs of treatment for port-occlusions and port-infections at 6 and 12 months after port insertion [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2004
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To compare the rate of port failure, defined as the occurrence of port malfunction or port infection within 12 months after port insertion, in patients with cancer requiring long-term adjuvant intravenous chemotherapy undergoing insertion of a newly designed, FDA-approved Vortex® implantable vascular access port vs a conventional vascular access port.

Secondary

To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion.
To compare the rate of central vein thrombosis at 6 and 12 months after port insertion.
To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion.
To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion.
To compare the death from all causes.
To compare the incidence of port-related interventions at 6 and 12 months after port insertion.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

Arm I: Patients undergo insertion of the Vortex® implantable vascular access port. Patients then receive standard chemotherapy.
Arm II : Patients undergo insertion of a conventional vascular access port. Patients then receive standard chemotherapy.

All episodes of access to the port are documented for 12 months after port insertion. Information including the reason for port access and difficulty in access is collected. Complications, such as occlusion and infection, implant duration, and incidence of port-related interventions are assessed at 6 and 12 months after port insertion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months
- Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic
Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion

PATIENT CHARACTERISTICS:

Life expectancy ≥ 6 months
No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following:
- Current skin infection
- Cutaneous lymphoma
- Auto-immune disorders
- Active vasculitis
- Connective tissue diseases
No known active infection requiring antibiotic therapy at the time of port implantation
- Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible
No concurrent illness requiring chronic anticoagulation
- Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607880

Locations

United States, Florida
Mayo Clinic - Jacksonville	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Albert G. Hakaim, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000581354, MAYO-5204
Study First Received:	February 1, 2008
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00607880 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

vascular access device complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009