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Ketorolac in Breast Cancer Surgery (KBCt)

U

Université Catholique de Louvain

Status and phase

Completed
Phase 3

Conditions

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

Treatments

Drug: Placebos
Drug: Ketorolac 30 mg IV

Study type

Interventional

Funder types

Other

Identifiers

NCT01806259
KBCtrial

Details and patient eligibility

About

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.

Enrollment

203 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 )

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

203 participants in 2 patient groups, including a placebo group

ketorolac 30 mg
Experimental group
Description:
Active drug to be compared with placebo
Treatment:
Drug: Ketorolac 30 mg IV
NaCl 0.9% 3mL
Placebo Comparator group
Description:
Placebo looking like the Active drug
Treatment:
Drug: Placebos

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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