CompletedPhase 3

Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy

France39 participantsStarted 2015-05-22

Plain-language summary

The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations

Who can participate

Age range

18 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: * Male or female * More than 18 years old * Proven histological cancer with bone metastasis * SignedInform consent form * Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session Exclusion Criteria: * VAS\>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session * Any SAO treatment on going * Pregnant or lactating woman * Hypersensitivity or safety issues to any opioïd treatment * Poor nasal mucosa (defined on clinical doctor assessment) * Severe obstructive lung conditions or respiratory depression * Renal insufficiency with creatinine clearance inferior to 45 ml/min * Hepatic insufficiency * Patient misunderstanding of the content and objective of the trial * Patient under supervision or guardianship * SAO intake 4 hours before the radiotherapy session * Patient participating to any other pain management trial * Morphine pump usage

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.

What they're measuring

Drug efficacy

Timeframe: 30 minutes

Trial details

NCT IDNCT02426697

SponsorCentre Henri Becquerel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-24

View on ClinicalTrials.gov More Bone Metastasis trials

Who can participate

Age range

18 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.