Ketorolac in Breast Cancer Surgery (KBCt)

• ClinicalTrials.gov Identifier: NCT01806259
• Recruitment Status: Completed
• First Posted: March 7, 2013
• Results First Posted: January 18, 2020
• Last Update Posted: April 7, 2020
• Sponsor: Université Catholique de Louvain
• Collaborator: Anticancer Fund, Belgium
• Information provided by (Responsible Party): Patrice Forget, Université Catholique de Louvain

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.

Condition or disease	Intervention/treatment	Phase
Curative Breast Cancer Surgery; Inflammatory Positive/Negative Status; Pre Surgical Incision Administration	Drug: Ketorolac 30 mg IV; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 203 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: ketorolac 30 mg; Active drug to be compared with placebo	Drug: Ketorolac 30 mg IV; Active drug; Other Name: ketorolac tromethamine
Placebo Comparator: NaCl 0.9% 3mL; Placebo looking like the Active drug	Drug: Placebos; Placebo looking like the Active drug; Other Name: NaCl 0.9%

Outcome Measures

Primary Outcome Measures :

1. Recurrence-free Survival [ Time Frame: 5 years ]
   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)

Other Outcome Measures:

1. Overall Survival [ Time Frame: 5 years ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 )

Contacts and Locations

Locations

Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium, 1200

Sponsors and Collaborators

Université Catholique de Louvain

Anticancer Fund, Belgium

Investigators

• Principal Investigator: Patrice Forget, MD; Cliniques universitaires Saint-Luc

More Information

Additional Information:

Related Info 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Forget P, Berlière 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.

• Responsible Party: Patrice Forget, Docteur, Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT01806259
• Other Study ID Numbers: KBCtrial
• First Posted: March 7, 2013
• Results First Posted: January 18, 2020
• Last Update Posted: April 7, 2020
• Last Verified: March 2020

Additional relevant MeSH terms:

Breast Neoplasms; Surgical Wound; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Wounds and Injuries; Ketorolac; Ketorolac Tromethamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action