Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy

Condition(s) targeted: Cancer-Related Problem/Condition; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: adjuvant therapy (Procedure); catheter management (Procedure); chemotherapy (Procedure); vascular access device placement (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Albert G. Hakaim, MD, Principal Investigator, Affiliation: Mayo Clinic

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.

Official title: A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy

Study design: Supportive Care, Randomized, Double-Blind

Primary outcome:

Port malfunction due to partial or total occlusion at 6 and 12 months after port insertion

Port infection at 6 and 12 months after port insertion

Secondary outcome:

Central vein thrombosis at 6 and 12 months after port insertion

Death from all causes

Port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion

Termination of use of the indwelling port at 6 and 12 months after port insertion

Calculation of direct costs of treatment for port-occlusions and port-infections at 6 and 12 months after port insertion

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2004
Last updated: October 18, 2008