A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy
All vascular access strategies foradministering chemotherapy in early stage breast cancer (EBC) are associated with risks and benefits. As the most effective type of access is unknown a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.
The trial methodology utilized broad eligibility criteria and the integrated consent model incorporating oral consent. EBC patients receiving non-trastuzumab-containing chemotherapy were randomized to peripheral access or central line insertion. The a priori definition of feasibility was: > 25% of patients approached agreed to randomisation and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications.
Of 159 patients approached, 150 (94.3%) agreed to randomisation, 77 (51.3%) were randomized to peripheral and 73 (48.7%) to central access. 6/26 (23.1%) of medical oncologists approached patients. Rates of complications per chemotherapy cycles in the peripheral vs central access groups with risk difference (RD) (95% CI) were: thrombotic events requiring anticoagulation [1 (0.3%) vs. 3 (1.0%), RD − 0.7(− 1.9,0.5)], line infections [0 (0%) vs. 1 (0.3%), RD − 0.3(− 0.9,0.3)], phlebitis [2 (0.6%) vs. 0 (0%), RD 0.3(− 0.3,0.8)], and tissue infiltrations [4 (1.1%) vs. 1 (0.3%), RD 0.8(− 0.4,2.1)]. Overall, 8.0% (6/75) and 7.7% (5/65) of patients had at least one of these complications in the peripheral and central access arms respectively [RD − 0.9(− 9.4,7.6)]. The study was terminated early due to slow accrual.
While meeting its a priori feasibility criteria for patient engagement, the slow accrual means that conducting a large pragmatic trial would require overcoming the barriers to physician recruitment.
TRIAL REGISTRATION: NCT02688998
KeywordsVascular access Integrated consent model Breast cancer Chemotherapy
We are grateful for patients and their families for their assistance with this study. Accrual by physician was: Clemons (142), Robinson (3), Mates (2), Parulekar (2) and Joy (1). We are grateful to Sheryl McDiarmid RN, Drs Chris Booth, Nathalie Levasseur and Matthew McInnes for their insight into protocol development.
This study was funded through the Rethinking Clinical Trials (REaCT) program.
Compliance with ethical standards
Conflict of interest
Dr. Awan reports participating in the Novartis Canada Advisory Board on the use of Ribociclib. Dr. Hutton reports personal fees from Cornerstone Research, outside the submitted work. The remaining authors declare that they have no conflicts of interest (Robinson, Stober, Fergusson, Kehoe, Bedard, MacDonald, Brunet, Saunders, Mazzarello, Vandermeer, Joy, Basulaiman, Mallick, and Clemons).
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 7.ClinicalTrials.gov. REaCT-vascular access Her2 negative vascular access strategies for (Neo) adjuvant breast cancer treatment without trastuzumab (OTT 15-07). 2017 [cited 2017 April 18]; https://clinicaltrials.gov/ct2/show/NCT02688998