Ketorolac in Breast Cancer Surgery

NCT ID: NCT01806259

Last Updated: 2020-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketorolac 30 mg

Active drug to be compared with placebo

Group Type EXPERIMENTAL

Ketorolac 30 mg IV

Intervention Type DRUG

Active drug

NaCl 0.9% 3mL

Placebo looking like the Active drug

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo looking like the Active drug

Interventions

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Ketorolac 30 mg IV

Active drug

Intervention Type DRUG

Placebos

Placebo looking like the Active drug

Intervention Type DRUG

Other Intervention Names

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ketorolac tromethamine NaCl 0.9%

Eligibility Criteria

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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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anticancer Fund, Belgium

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Patrice Forget

Docteur

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrice Forget, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 20435950 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31800611 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23937996 (View on PubMed)

Related Links

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Other Identifiers

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KBCtrial

Identifier Type: -

Identifier Source: org_study_id

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