Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachythe… (NCT02439034) | Clinical Trial Compass
CompletedPhase 2
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
France68 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.