- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282449
Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy
Assessment of a Power Injectable vs. a Non-Power Injectable, Upper Arm, Totally Implanted Venous Access Devices for Chemotherapy
Patients with cancer often require intravenous chemotherapy for long periods of time.
Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins.
A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing.
Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.
Study Overview
Status
Conditions
Detailed Description
Hypothesis:
The null hypothesis envisions both devices performing similarly in regards to chemotherapy and complications. However, the power injectable population will experience the high flow, large volume injections, may experience complications of injection extravasation and port damage due to the more vigorous injection parameters.
Trial Objectives:
- To prospectively assess the functionality and complications of a power injectable vs. a non-power injectable TIVAD in a cohort of breast cancer patients requiring intravenous chemotherapy. The TIVAD will be randomly assigned to each patient.
- Assess quality of life for subjects who have the two different TIVADs.
- Facilitate device selection for future cancer patients requiring chemotherapy.
We will perform a randomized, prospective clinical trial of patients with cancer to compare a non-power injectable port, Cook Vital Mini Port (Cook Canada, Mississauga, ON), with a power injectable port, the AngioDynamics Smart Port CT Mini (AngioDynamics Inc., Manchester, GA, USA).
Adverse events, such as arm swelling, skin rash, and incision dehiscence, etc., will be tracked via an online reporting system, a patient registry, and by follow-up strategies related to imaging and clinical assessments at regular time intervals.
Patient Follow-up:
From the Insertion date, a 7 day post insertion telephone interview will be performed. Subsequently the following will be obtained at 3 months and 12 months post port insertion.
Clinical examination Venous Doppler US (arm/neck) Chest and arm X-ray QLQC30 questionnaire QLAVD-PA questionnaire Adverse Event Record
Details of Follow-up:
Clinical Examination:
Visual inspection of the arm, port implantation site, neck, and anterior chest.
- Distended arm, neck or chest veins - Y/N - details
- Swollen or edematous arm, neck, chest - Y/N - details
- Skin rash - Y/N - details
- Signs of arm infection - redness, swelling, purulent discharge - Y/N - details
- Abnormal incision site of port insertion - Y/N - details
Venous Doppler Ultrasound (arm/neck):
Ultrasound will assess for vein thrombosis or narrowing.
Chest and arm x-rays:
Standard x-rays to include the arm from at least the elbow to axilla, full chest x-ray.
QLCC30 and QLAVD-PA:
Quality of Life surveys.
Adverse Events:
7 days, 3 months, 12 months, up to 24 months if possible - The patient will be contacted by telephone to determine if they have experienced any adverse events.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Medical Imaging, Royal University Hospital, 103 Hospital Drive
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included.
Exclusion Criteria:
• Those under the age of 16 years;
- Those with uncorrectable blood clotting disorder;
- Pregnant women, as they will not be candidates for chemotherapy;
- Any person with an active infection or immunocompromised state;
- Those on oral or intravenous antibiotics on the day of TIVAD implantation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Power Injectable Port
The subjects randomized to this group will receive the newer, power injectable port.
|
The subjects will all receive power injectable port.
|
Active Comparator: Non-Power Injectable Port
The subjects randomized to this group will receive the older, non-power injectable port.
|
The subjects will all receive non-power injectable port.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
Time Frame: 2 years after insertion
|
Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence
|
2 years after insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Venous Thrombosis
Time Frame: 2 years after implantation
|
Ipsilateral US of veins of arm and neck to detect venous thrombosis
|
2 years after implantation
|
Quality of Life Related to Port
Time Frame: 2 years after implantation
|
Surveys of quality of life will be performed for each device
|
2 years after implantation
|
Infection
Time Frame: 2 years after implantation
|
Detect implantation site or systemic infection related to the port.
|
2 years after implantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brent E Burbridge, MD, FRCPC, Medical Imaging, 103 Hospital Drive, Royal University Hospital, Saskatoon, SK, Canada S7N 0W8
Publications and helpful links
General Publications
- Goossens GA, Stas M, Jerome M, Moons P. Systematic review: malfunction of totally implantable venous access devices in cancer patients. Support Care Cancer. 2011 Jul;19(7):883-98. doi: 10.1007/s00520-011-1171-3. Epub 2011 May 10.
- Marcy PY, Chamorey E, Amoretti N, Benezery K, Bensadoun RJ, Bozec A, Poissonnet G, Dassonville O, Rame M, Italiano A, Peyrade F, Brenac F, Gallard JC. A comparison between distal and proximal port device insertion in head and neck cancer. Eur J Surg Oncol. 2008 Nov;34(11):1262-9. doi: 10.1016/j.ejso.2007.09.011. Epub 2007 Nov 5.
- Goltz JP, Machann W, Noack C, Hahn D, Kickuth R. Feasibility of power contrast injections and bolus triggering during CT scans in oncologic patients with totally implantable venous access ports of the forearm. Acta Radiol. 2011 Feb 1;52(1):41-7. doi: 10.1258/ar.2010.100238.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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