Uterine Cervical CancerPhase 2KETOCOLNCT02439034
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
A Phase 2 study testing Paracetamol and Ketoprofen in people with Uterine Cervical Cancer and Upper Aerodigestive Tract Neoplasms, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uterine Cervical Cancer, Upper Aerodigestive Tract Neoplasms
- What is being tested?
- Paracetamol and Ketoprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Paracetamol, Ketoprofen
- Keywords
- pain management, brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Head and Neck Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called PARACETAMOL B BRAUN, PARACETAMOL CODEINE ARROW, Acetaminophen
Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
KetoprofenDrug
Also called BI PROFENID LP, PROFENID
Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Paracetamol Receives: Drug: Paracetamol |
| Arm B | Experimental | Paracetamol + Ketoprofen Receives: Drug: Paracetamol; Drug: Ketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1 (8, 12 hours), Days 3, 15 and 30
Tolerance of the analgesic treatment
assessment based on NCI-CTCAE v4.0
Measured: 30 days
Assessment of anxiety
before, during and after brachytherapy by completing the HADS questionnaire
Measured: inclusion, Days 3 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association
- Responsible party
- Sponsor
- Investigators
- Danièle LEFEBVRE-KUNTZ, MD, Study director, Centre Oscar LambretNathalie LEROUX, MD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439034
- Sponsor's protocol ID
- KETOCOL-1304
- Other IDs
- 2013-005510-35
- Acronym
- KETOCOL
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2015
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02439034
- Acronym / sponsor ID
- KETOCOL / KETOCOL-1304
- Keywords
- pain management, brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Santelys Association
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: ParacetamolParacetamol |
| Arm B | Experimental | Drug: Paracetamol, Drug: KetoprofenParacetamol + Ketoprofen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: PARACETAMOL B BRAUN, PARACETAMOL CODEINE ARROW, AcetaminophenParacetamol 1 g IV then 1 g 3 times a day IV or oral (PO) | Drug | Arm A, Arm B |
| KetoprofenAlso: BI PROFENID LP, PROFENIDKetoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day. | Drug | Arm B |
Primary outcome
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.
3 secondary outcomes
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
Tolerance of the analgesic treatment
Time frame: 30 days
Assessment of anxiety
Time frame: inclusion, Days 3 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danièle LEFEBVRE-KUNTZ, MD study director
Centre Oscar Lambret
Nathalie LEROUX, MD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paracetamol and Ketoprofen in people with Uterine Cervical Cancer and Upper Aerodigestive Tract Neoplasms, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of immediate post-operative pain (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.