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Ketorolac in Breast Cancer Surgery (KBCt)

Primary Purpose

Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Ketorolac 30 mg IV
Placebos
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Curative Breast Cancer Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes

Exclusion Criteria:

Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ketorolac 30 mg

NaCl 0.9% 3mL

Arm Description

Active drug to be compared with placebo

Placebo looking like the Active drug

Outcomes

Primary Outcome Measures

Recurrence-free Survival
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

Secondary Outcome Measures

Full Information

First Posted
February 20, 2013
Last Updated
March 26, 2020
Sponsor
Université Catholique de Louvain
Collaborators
Anticancer Fund, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT01806259
Brief Title
Ketorolac in Breast Cancer Surgery
Acronym
KBCt
Official Title
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
Collaborators
Anticancer Fund, Belgium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Curative Breast Cancer Surgery, Inflammatory Positive/Negative Status, Pre Surgical Incision Administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketorolac 30 mg
Arm Type
Experimental
Arm Description
Active drug to be compared with placebo
Arm Title
NaCl 0.9% 3mL
Arm Type
Placebo Comparator
Arm Description
Placebo looking like the Active drug
Intervention Type
Drug
Intervention Name(s)
Ketorolac 30 mg IV
Other Intervention Name(s)
ketorolac tromethamine
Intervention Description
Active drug
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
Placebo looking like the Active drug
Primary Outcome Measure Information:
Title
Recurrence-free Survival
Description
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Overall Survival
Description
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes Exclusion Criteria: Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Forget, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20435950
Citation
Forget P, Vandenhende J, Berliere M, Machiels JP, Nussbaum B, Legrand C, De Kock M. Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg. 2010 Jun 1;110(6):1630-5. doi: 10.1213/ANE.0b013e3181d2ad07. Epub 2010 Apr 30.
Results Reference
background
PubMed Identifier
31800611
Citation
Forget P, Bouche G, Duhoux FP, Coulie PG, Decloedt J, Dekleermaker A, Guillaume JE, Ledent M, Machiels JP, Mustin V, Swinnen W, van Maanen A, Vander Essen L, Verougstraete JC, De Kock M, Berliere M. Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS One. 2019 Dec 4;14(12):e0225748. doi: 10.1371/journal.pone.0225748. eCollection 2019.
Results Reference
derived
PubMed Identifier
23937996
Citation
Forget P, Berliere M, van Maanen A, Duhoux FP, Machiels JP, Coulie PG, Bouche G, De Kock M; Ketorolac in Breast Cancer trial (KBCtrial) group. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial. Med Hypotheses. 2013 Oct;81(4):707-12. doi: 10.1016/j.mehy.2013.07.033. Epub 2013 Aug 9.
Results Reference
derived
Links:
URL
http://www.anesthesia-analgesia.org
Description
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Ketorolac in Breast Cancer Surgery

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