search
Back to results

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

Primary Purpose

Uterine Cervical Cancer, Upper Aerodigestive Tract Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paracetamol
Ketoprofen
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Cancer focused on measuring pain management, brachytherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar LambretRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Paracetamol

Paracetamol + Ketoprofen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Tolerance of the analgesic treatment
assessment based on NCI-CTCAE v4.0
Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire

Full Information

First Posted
April 30, 2015
Last Updated
July 27, 2016
Sponsor
Centre Oscar Lambret
Collaborators
Santelys Association
search

1. Study Identification

Unique Protocol Identification Number
NCT02439034
Brief Title
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
Acronym
KETOCOL-1304
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Santelys Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain : 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer, Upper Aerodigestive Tract Neoplasms
Keywords
pain management, brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Paracetamol
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Paracetamol + Ketoprofen
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
PARACETAMOL B BRAUN, PARACETAMOL CODEINE ARROW
Intervention Description
Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Other Intervention Name(s)
BI PROFENID LP, PROFENID
Intervention Description
Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.
Primary Outcome Measure Information:
Title
Level of immediate post-operative pain
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Level of pain linked to the operative procedure during brachytherapy and at home
Description
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.
Time Frame
Day 1 (8, 12 hours), Days 3, 15 and 30
Title
Tolerance of the analgesic treatment
Description
assessment based on NCI-CTCAE v4.0
Time Frame
30 days
Title
Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire
Time Frame
inclusion, Days 3 and 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danièle LEFEBVRE-KUNTZ, MD
Phone
+33 3 20 29 59 89
Email
d-lefebvre@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie LEROUX-BROMBERG, MD
Phone
+33 3 20 29 59 89
Email
n-leroux@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danièle LEFEBVRE-KUNTZ, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nathalie LEROUX, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danièle Lefebvre-Kuntz, MD
Phone
+33 3 20 29 59 89
Email
d-lefebvre@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Nathalie Leroux-Bromberg, MD
Phone
+33 3 20 29 59 89
Email
n-leroux@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Danièle Lefebvre-Kuntz, MD
First Name & Middle Initial & Last Name & Degree
Nathalie Leroux-Bromberg, MD
First Name & Middle Initial & Last Name & Degree
Abesse Ahmeidi, MD
First Name & Middle Initial & Last Name & Degree
Agnès Hamdani, MD
First Name & Middle Initial & Last Name & Degree
Eliane Boufflers, MD
First Name & Middle Initial & Last Name & Degree
Eric Lartigau, MD
First Name & Middle Initial & Last Name & Degree
Bernard Coche-Dequeant, MD
First Name & Middle Initial & Last Name & Degree
Abel Cordoba, MD
First Name & Middle Initial & Last Name & Degree
Sophie Maillard, MD
First Name & Middle Initial & Last Name & Degree
Didier Delbrouck, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs