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

Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Cervical Cancer; Upper Aerodigestive Tract Neoplasms
• Intervention / Treatment: Drug: Paracetamol; Drug: Ketoprofen

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Danièle Lefebvre-Kuntz, MD; Phone Number: +33 3 20 29 59 89; Email: d-lefebvre@o-lambret.fr
• Study Contact Backup: Name: Nathalie Leroux-Bromberg, MD; Phone Number: +33 3 20 29 59 89; Email: n-leroux@o-lambret.fr

Study Locations

• France
  • Lille, France, 59020
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Danièle Lefebvre-Kuntz, MD; Phone Number: +33 3 20 29 59 89; Email: d-lefebvre@o-lambret.fr
    • Contact: Nathalie Leroux-Bromberg, MD; Phone Number: +33 3 20 29 59 89; Email: 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: Sophie Maillard, MD
    • Sub-Investigator: Didier Delbrouck, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of immediate post-operative pain	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pain linked to the operative procedure during brachytherapy and at home	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.	Day 1 (8, 12 hours), Days 3, 15 and 30
Tolerance of the analgesic treatment	assessment based on NCI-CTCAE v4.0	30 days
Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire		inclusion, Days 3 and 30

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Santelys Association
• Investigators: Study Director: Danièle LEFEBVRE-KUNTZ, MD, Centre Oscar Lambret; Study Director: Nathalie LEROUX, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: brachytherapy; pain management
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ketoprofen; Codeine
• Other Study ID Numbers: KETOCOL-1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO