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Breast Cancer Research and Treatment

, Volume 178, Issue 2, pp 337–345 | Cite as

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

  • Andrew Robinson
  • Carol Stober
  • Dean Fergusson
  • Anne Kehoe
  • Debbie Bedard
  • Fiona MacDonald
  • Marie-Claude Brunet
  • Deanna Saunders
  • Sasha Mazzarello
  • Lisa Vandermeer
  • Anil A. Joy
  • Arif Awan
  • Bassam Basulaiman
  • Ranjeeta Mallick
  • Brian Hutton
  • Mark ClemonsEmail author
  • the REaCT investigators
Clinical trial

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

Keywords

Vascular access Integrated consent model Breast cancer Chemotherapy 

Notes

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.

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).

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.

References

  1. 1.
    Lipitz-Snyderman A et al (2015) Complications associated with use of long-term central venous catheters among commercially insured women with breast cancer. J Oncol Pract 11(6):505–510CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Chopra V et al (2013) Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis. Lancet 382(9889):311–325CrossRefPubMedGoogle Scholar
  3. 3.
    LeVasseur N et al (2018) Optimizing vascular access for patients receiving intravenous systemic therapy for early-stage breast cancer-a survey of oncology nurses and physicians. Curr Oncol 25(4):e298–e304PubMedPubMedCentralGoogle Scholar
  4. 4.
    LeVasseur N et al (2018) Perceptions of vascular access for intravenous systemic therapy and risk factors for lymphedema in early-stage breast cancer—a patient survey. Curr Oncol 25(4):e305–e310PubMedPubMedCentralGoogle Scholar
  5. 5.
    Krein SL et al (2019) Patient-reported complications related to peripherally inserted central catheters: a multicentre prospective cohort study. BMJ Qual Saf 28(7):574CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Hilton J et al (2016) Novel methodology for comparing standard-of-care interventions in patients with cancer. J Oncol Pract 12:e1016–e1024CrossRefPubMedGoogle Scholar
  7. 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
  8. 8.
    Robinson A et al (2018) Optimal vascular access strategies for patients receiving chemotherapy for early-stage breast cancer: a systematic review. Breast Cancer Res Treat 171:1–14CrossRefGoogle Scholar
  9. 9.
    Kim SY, Miller FG (2014) Informed consent for pragmatic trials–the integrated consent model. N Engl J Med 370(8):769–772CrossRefPubMedGoogle Scholar
  10. 10.
    Sugarman J, Califf RM (2014) Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311(23):2381–2382CrossRefPubMedGoogle Scholar
  11. 11.
    Doellman D et al (2009) Infiltration and extravasation: update on prevention and management. J Infus Nurs 32(4):203–211CrossRefPubMedGoogle Scholar
  12. 12.
    Singh KR et al (2014) Morbidity of chemotherapy administration and satisfaction in breast cancer patients: a comparative study of totally implantable venous access device (TIVAD) versus peripheral venous access usage. World J Surg 38(5):1084–1092CrossRefPubMedGoogle Scholar
  13. 13.
    Di Carlo I et al (2001) Totally implantable venous access devices implanted surgically: a retrospective study on early and late complications. Arch Surg 136(9):1050–1053CrossRefPubMedGoogle Scholar
  14. 14.
    Ozyuvaci E, Kutlu F (2006) Totally implantable venous access devices via subclavian vein: a retrospective study of 368 oncology patients. Adv Ther 23(4):574–581CrossRefPubMedGoogle Scholar
  15. 15.
    Piran S et al (2014) Incidence and risk factors of symptomatic venous thromboembolism related to implanted ports in cancer patients. Thromb Res 133(1):30–33CrossRefPubMedGoogle Scholar
  16. 16.
    Vescia S et al (2008) Management of venous port systems in oncology: a review of current evidence. Ann Oncol 19(1):9–15CrossRefPubMedGoogle Scholar
  17. 17.
    Aw A et al (2012) Incidence and predictive factors of symptomatic thrombosis related to peripherally inserted central catheters in chemotherapy patients. Thromb Res 130(3):323–326CrossRefPubMedGoogle Scholar
  18. 18.
    Showalter SL et al (2013) Lifestyle risk factors associated with arm swelling among women with breast cancer. Ann Surg Oncol 20(3):842–849CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Andrew Robinson
    • 1
  • Carol Stober
    • 2
  • Dean Fergusson
    • 3
    • 4
  • Anne Kehoe
    • 5
  • Debbie Bedard
    • 6
  • Fiona MacDonald
    • 6
  • Marie-Claude Brunet
    • 6
  • Deanna Saunders
    • 2
  • Sasha Mazzarello
    • 2
  • Lisa Vandermeer
    • 2
  • Anil A. Joy
    • 7
  • Arif Awan
    • 5
  • Bassam Basulaiman
    • 5
  • Ranjeeta Mallick
    • 4
  • Brian Hutton
    • 3
    • 4
  • Mark Clemons
    • 2
    • 3
    • 4
    • 5
    Email author
  • the REaCT investigators
  1. 1.Division of Medical OncologyCancer Centre of Southeastern OntarioKingstonCanada
  2. 2.Cancer Therapeutics ProgramOttawa Hospital Research InstituteOttawaCanada
  3. 3.Department of MedicineUniversity of OttawaOttawaCanada
  4. 4.Clinical Epidemiology ProgramOttawa Hospital Research InstituteOttawaCanada
  5. 5.Division of Medical Oncology, Department of MedicineThe Ottawa Hospital and University of OttawaOttawaCanada
  6. 6.Department of NursingThe Ottawa HospitalOttawaCanada
  7. 7.Division of Medical Oncology, Department of OncologyUniversity of Alberta, Cross Cancer InstituteEdmontonCanada

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