Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy

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.

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.