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NCT01806259 Clinical Trial

Ketorolac in Breast Cancer Surgery

Curative Breast Cancer Surgery Clinical Trial

— KBCt  

Official title:
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01806259
Other study ID # KBCtrial
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2013
Est. completion date September 2018

Study information
Verified date March 2020
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date September 2018
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 )

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketorolac 30 mg IV
Active drug
• Placebos
Placebo looking like the Active drug

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels

Sponsors (2)
Lead Sponsor Collaborator
Université Catholique de Louvain Anticancer Fund, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Overall Survival 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) 5 years
Primary 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) 5 years

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