Ketorolac in Breast Cancer Surgery
Conditions
Curative Breast Cancer Surgery - Inflammatory Positive/Negative Status - Pre Surgical Incision Administration
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Ketorolac 30 mg IV
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
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 )
Location
Cliniques universitaires Saint-Luc
Brussels, Belgium
Status: Recruiting
Contact: Patrice Forget, MD - + 32 2 764 1441 - patrice.forget@uclouvain.be
Start Date
February 2013
Completion Date
August 2018
Sponsors
Université Catholique de Louvain
Source
Université Catholique de Louvain
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page