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Trial record 1 of 1 for:    NCT01806259
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Ketorolac in Breast Cancer Surgery (KBCt)

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ClinicalTrials.gov Identifier: NCT01806259
Recruitment Status : Unknown
Verified March 2017 by Forget Patrice, Université Catholique de Louvain.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2013
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Anticancer Fund, Belgium
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain

Study Description
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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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group 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.
Study Start Date : February 2013
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ketorolac

Arms and Interventions
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Arm Intervention/treatment
Experimental: ketorolac 30 mg
Active drug to be compared with placebo
 Drug: Ketorolac 30 mg IV
Placebo Comparator: NaCl 0.9% 3mL Drug: Ketorolac 30 mg IV


Outcome Measures
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Primary Outcome Measures :
  1. Effect of ketorolac on recurrence-free survival [ Time Frame: 5 years ]
    2 years for the primary analysis + 3 additional years for secondary analysis


Secondary Outcome Measures :
  1. efficacy of ketolorac in pain control [ Time Frame: 2 years ]
  2. Effect of ketorolac on inflammatory and growth factors [ Time Frame: 30 days ]
    Assessment of inflammatory markers (NLR, cytokines, angiogenic profile)


Other Outcome Measures:
  1. effect of ketorolac on overall survival [ Time Frame: 5 years ]

Eligibility Criteria
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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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806259


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Anticancer Fund, Belgium
Investigators
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Principal Investigator: Patrice Forget, MD Cliniques universitaires Saint-Luc
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

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

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Responsible Party: Forget Patrice, Docteur, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01806259     History of Changes
Other Study ID Numbers: KBCtrial
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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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