NCT00418457

Brief Summary

In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,108

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

11.1 years

First QC Date

January 3, 2007

Results QC Date

February 21, 2020

Last Update Submit

June 3, 2020

Conditions

Breast Neoplasms

Keywords

Breast CancerAnesthesia; regionalcancer recurrenceAnesthesia; inhalationalAnalgesia; opioid

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery

    time to breast cancer recurrence from the end of surgery.

    up to 10 years

Secondary Outcomes (4)

  • Number of Participants That Experienced Post-Surgical Pain

    6 months and 1 year

  • Number of Participants That Experienced Neuropathic Pain After Surgery

    6 month and 1 year

  • SF-12 PCS Score

    6 month and 1 year

  • SF-12 MCS Score

    6 month and 1 year

Study Arms (2)

General anesthesia and opioid

ACTIVE COMPARATOR

General anesthesia followed by opioid administration

Drug: General anesthesia and opioids

Regional analgesia and propofol

ACTIVE COMPARATOR

Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol

Drug: Regional analgesia and propofol

Interventions

General anesthesia and opioidsDRUG

General anesthesia, usually with sevoflurane, and opioid analgesia

Also known as: General anesthesia
General anesthesia and opioid
Regional analgesia and propofolDRUG

Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia

Also known as: Regional analgesia
Regional analgesia and propofol

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
  • Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
  • Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
  • Written informed consent, including willingness to be randomized to morphine or regional analgesia

You may not qualify if:

  • Previous surgery for breast cancer (except diagnostic biopsies)
  • Inflammatory breast cancer
  • Age \< 18 or \> 85 years old
  • Scheduled free flap reconstruction
  • ASA Physical Status ≥ 4
  • Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
  • Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
  • Other cancer not believed by the attending surgeon to be in long-term remission
  • Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Medical University of Vienna

Vienna, Austria

Location

Peking Union Medical College Hospital

Beijing, China

Location

University of Düsseldorf

Düsseldorf, 40225, Germany

Location

Mater Misericordiae Hospital

Dublin, 7, Ireland

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (9)

  • Li M, Zhang Y, Pei L, Zhang Z, Tan G, Huang Y. Potential Influence of Anesthetic Interventions on Breast Cancer Early Recurrence According to Estrogen Receptor Expression: A Sub-Study of a Randomized Trial. Front Oncol. 2022 Feb 10;12:837959. doi: 10.3389/fonc.2022.837959. eCollection 2022.

    PMID: 35223519DERIVED

  • Aghamelu O, Buggy P, Smith G, Inzitari R, Wall T, Buggy DJ. Serum NETosis expression and recurrence risk after regional or volatile anaesthesia during breast cancer surgery: A pilot, prospective, randomised single-blind clinical trial. Acta Anaesthesiol Scand. 2021 Mar;65(3):313-319. doi: 10.1111/aas.13745. Epub 2020 Nov 29.

    PMID: 33187020DERIVED

  • Sessler DI, Pei L, Huang Y, Fleischmann E, Marhofer P, Kurz A, Mayers DB, Meyer-Treschan TA, Grady M, Tan EY, Ayad S, Mascha EJ, Buggy DJ; Breast Cancer Recurrence Collaboration. Recurrence of breast cancer after regional or general anaesthesia: a randomised controlled trial. Lancet. 2019 Nov 16;394(10211):1807-1815. doi: 10.1016/S0140-6736(19)32313-X. Epub 2019 Oct 20.

    PMID: 31645288DERIVED

  • Levins KJ, Prendeville S, Conlon S, Buggy DJ. The effect of anesthetic technique on micro-opioid receptor expression and immune cell infiltration in breast cancer. J Anesth. 2018 Dec;32(6):792-796. doi: 10.1007/s00540-018-2554-0. Epub 2018 Sep 18.

    PMID: 30229370DERIVED

  • Kim R. Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle. Cancer Metastasis Rev. 2017 Mar;36(1):159-177. doi: 10.1007/s10555-016-9647-8.

    PMID: 27866303DERIVED

  • Pei L, Zhou Y, Tan G, Mao F, Yang D, Guan J, Lin Y, Wang X, Zhang Y, Zhang X, Shen S, Xu Z, Sun Q, Huang Y; Outcomes Research Consortium. Ultrasound-Assisted Thoracic Paravertebral Block Reduces Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer Surgery: A Randomized, Controlled, Single-Center Trial. PLoS One. 2015 Nov 20;10(11):e0142249. doi: 10.1371/journal.pone.0142249. eCollection 2015.

    PMID: 26588217DERIVED

  • Wu J, Buggy D, Fleischmann E, Parra-Sanchez I, Treschan T, Kurz A, Mascha EJ, Sessler DI. Thoracic paravertebral regional anesthesia improves analgesia after breast cancer surgery: a randomized controlled multicentre clinical trial. Can J Anaesth. 2015 Mar;62(3):241-51. doi: 10.1007/s12630-014-0285-8. Epub 2014 Dec 6.

    PMID: 25480319DERIVED

  • Jaura AI, Flood G, Gallagher HC, Buggy DJ. Differential effects of serum from patients administered distinct anaesthetic techniques on apoptosis in breast cancer cells in vitro: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i63-7. doi: 10.1093/bja/aet581. Epub 2014 Jul 9.

    PMID: 25009197DERIVED

  • Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.

    PMID: 25009196DERIVED

MeSH Terms

Conditions

Breast NeoplasmsAgnosia

Interventions

Anesthesia, GeneralAnalgesics, OpioidPropofol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Daniel Sessler, MD
Organization
Cleveland Clinic
sessled@ccf.org
216-444-4900

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2018

Study Completion

December 1, 2019

Last Updated

June 16, 2020

Results First Posted

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)IE(1)US(1)SG(1)CN(1)AU(1)