TerminatedPhase 3

Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery

Stopped: insufficient funding and recruitment

Switzerland126 participantsStarted 2018-01-09

Plain-language summary

This study will test the benefits and risks of using pregabalin perioperatively to prevent persistent postoperative pain in patients at high risk (\>30%) of developing such pain after breast cancer surgery.

Who can participate

Age range

18 Years

Sex

FEMALE

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: * patients scheduled for breast surgery for cancer, either breast-conserving (tumorectomy/ quadrantectomy) or mastectomy, with or without immediate reconstruction, and with or without axillary dissection. * patients of 18 years or more scheduled for above mentioned type of surgery * ability to speak and read French, English or German * high (\>30%) risk of clinically important persistent pain: identified with 2 or more points of a risk score including the items: pre-existing pain at surgical site (2 points), history of depression (1 point), age \< 50 years (1 point), and high expected acute pain (\>6/10, 1 point). * Informed Consent as documented by signature. Exclusion Criteria: * Inability to understand the consent form and to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons * Pregnancy or lactation - Renal insufficiency (creatinine clearance \< 60 ml/min) * Allergy to pregabalin or the ingredients of the capsules * Long-term preoperative therapy with gabapentinoids or high-dose opioids (more than 60 mg of morphine equivalents) * Symptomatic cardiac insufficiency (peripheral oedema, NYHA class III - marked limitation of ph…

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.

1This trial was terminated before it completed — do you know why it was stopped, and does that affect how much we can trust any results that came out of it?
2This study was specifically looking at patients considered 'high risk' for developing persistent pain after breast cancer surgery — do you think I fall into that high-risk category, and how does that change my options?
3The trial was testing pregabalin to prevent long-term pain after breast cancer surgery, which is a real concern I hadn't thought about — how common is persistent postoperative pain after the type of surgery I'm having, and what strategies do you currently use to reduce that risk?
4Since this was a Phase 3 trial that was terminated, is pregabalin something that's already used in practice for this purpose, or is preventing persistent pain after breast cancer surgery still considered an open question?
5Are there other completed studies or current standard approaches for preventing long-term pain after breast cancer surgery that we should be discussing as part of my overall surgical plan?

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

incidence of "clinically important pain" at 3 months after surgery

Timeframe: 3 months

Trial details

NCT IDNCT03216187

SponsorBenno Rehberg-Klug

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-11

View on ClinicalTrials.gov More Persistent Postoperative Pain trials