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Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304) (KETOCOL-1304)

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ClinicalTrials.gov Identifier: NCT02439034
Recruitment Status : Unknown
Verified July 2016 by Centre Oscar Lambret.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : July 28, 2016
Sponsor:
Collaborator:
Santélys
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.

Condition or disease Intervention/treatment Phase
Uterine Cervical Cancer Upper Aerodigestive Tract Neoplasms Drug: Paracetamol Drug: Ketoprofen Phase 2

Detailed Description:
  • Selection criteria validation
  • Patient information and collection of a signed informed consent
  • Randomization
  • Completion of HADS questionnaire
  • Day 1 = Begin of analgesic treatment / brachytherapy
  • T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
  • T0= end of the operative procedure under general anesthesia
  • T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:

    1. paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
    2. paracetamol and morphine (Arms A and B)
  • Day 2 to Day 30: At home or during hospital stay:

Pain assessment twice a day by the patient until absence of pain during 2 consecutive days

  • Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
  • Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire

In any case, pain assessment must be done until absence of pain during 2 consecutive days


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen

Arm Intervention/treatment
Active Comparator: Arm A
Paracetamol
Drug: Paracetamol
Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
Other Names:
  • PARACETAMOL B BRAUN
  • PARACETAMOL CODEINE ARROW

Experimental: Arm B
Paracetamol + Ketoprofen
Drug: Paracetamol
Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
Other Names:
  • PARACETAMOL B BRAUN
  • PARACETAMOL CODEINE ARROW

Drug: Ketoprofen
Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.
Other Names:
  • BI PROFENID LP
  • PROFENID




Primary Outcome Measures :
  1. Level of immediate post-operative pain [ Time Frame: Day 1 ]
    Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is < 4, 4 hours after the surgical operation.


Secondary Outcome Measures :
  1. Level of pain linked to the operative procedure during brachytherapy and at home [ Time Frame: Day 1 (8, 12 hours), Days 3, 15 and 30 ]
    Assessment of the pain level at 8, 12 hours after the operative procedure, then twice a day during hospital stay or at home until the absence of pain during 2 consecutive days. This level will also be measured at days 3, 15 and 30 at hospital or during a phone interview (Days 3 and 15) and by the algologist of the investigation center on Day 30.

  2. Tolerance of the analgesic treatment [ Time Frame: 30 days ]
    assessment based on NCI-CTCAE v4.0

  3. Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire [ Time Frame: inclusion, Days 3 and 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a uterine cervical cancer or an upper aero-digestive tract cancer
  • Age ≥ 18 years and ≤ 75 years
  • Patient who are eligible for brachytherapy treatment associated with or without hospital stay
  • With operative procedure under general anesthesia to set up the material needed for brachytherapy
  • Performance status ≤ 2
  • Creatinine Clearance ≥ 60 ml/min using Cockcroft equation
  • No coagulation disorder or anticoagulation therapy at curative dose
  • Registered with a social security system
  • Patient having dated and signed an informed consent form before initiation of any study procedures

Exclusion Criteria:

  • Respiratory pathology (SpO2< 70 %)
  • Severe undernutrition
  • Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs
  • Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID
  • Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage
  • Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified)
  • Liver insufficiency
  • Severe renal insufficiency
  • Severe heart failure
  • Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors
  • Intolerance or hypersensitivity to one of the treatments or excipients
  • Inability to swallow
  • Pregnant or breastfeeding woman
  • Patient under tutorship or guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439034


Contacts
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Contact: Danièle LEFEBVRE-KUNTZ, MD +33 3 20 29 59 89 d-lefebvre@o-lambret.fr
Contact: Nathalie LEROUX-BROMBERG, MD +33 3 20 29 59 89 n-leroux@o-lambret.fr

Locations
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France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Danièle Lefebvre-Kuntz, MD    +33 3 20 29 59 89    d-lefebvre@o-lambret.fr   
Contact: Nathalie Leroux-Bromberg, MD    +33 3 20 29 59 89    n-leroux@o-lambret.fr   
Principal Investigator: Danièle Lefebvre-Kuntz, MD         
Sub-Investigator: Nathalie Leroux-Bromberg, MD         
Sub-Investigator: Abesse Ahmeidi, MD         
Sub-Investigator: Agnès Hamdani, MD         
Sub-Investigator: Eliane Boufflers, MD         
Sub-Investigator: Eric Lartigau, MD         
Sub-Investigator: Bernard Coche-Dequeant, MD         
Sub-Investigator: Abel Cordoba, MD         
Sub-Investigator: Sophie Maillard, MD         
Sub-Investigator: Didier Delbrouck, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Santélys
Investigators
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Study Director: Danièle LEFEBVRE-KUNTZ, MD Centre Oscar Lambret
Study Director: Nathalie LEROUX, MD Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02439034     History of Changes
Other Study ID Numbers: KETOCOL-1304
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
pain management
brachytherapy
Additional relevant MeSH terms:
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Acetaminophen
Uterine Cervical Neoplasms
Head and Neck Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Ketoprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action