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A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy

  • Clinical trial
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Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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

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Acknowledgements

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.

Funding

This study was funded through the Rethinking Clinical Trials (REaCT) program.

Author information

Authors and Affiliations

  1. Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada

    Andrew Robinson

  2. Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Carol Stober, Deanna Saunders, Sasha Mazzarello, Lisa Vandermeer & Mark Clemons

  3. Department of Medicine, University of Ottawa, Ottawa, Canada

    Dean Fergusson, Brian Hutton & Mark Clemons

  4. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada

    Dean Fergusson, Ranjeeta Mallick, Brian Hutton & Mark Clemons

  5. Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada

    Anne Kehoe, Arif Awan, Bassam Basulaiman & Mark Clemons

  6. Department of Nursing, The Ottawa Hospital, Ottawa, Canada

    Debbie Bedard, Fiona MacDonald & Marie-Claude Brunet

  7. Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, AB, Canada

    Anil A. Joy

Authors
  1. Andrew Robinson
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  2. Carol Stober
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  3. Dean Fergusson
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  9. Sasha Mazzarello
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  10. Lisa Vandermeer
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  12. Arif Awan
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  13. Bassam Basulaiman
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  14. Ranjeeta Mallick
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  15. Brian Hutton
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  16. Mark Clemons
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Consortia

the REaCT investigators

Corresponding author

Correspondence to Mark Clemons.

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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).

Ethical approval

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

Informed consent was obtained from all individual participants included in the study.

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Robinson, A., Stober, C., Fergusson, D. et al. A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Breast Cancer Res Treat 178, 337–345 (2019). https://doi.org/10.1007/s10549-019-05388-5

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  • DOI: https://doi.org/10.1007/s10549-019-05388-5

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