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Pain prevention drug fails to prove benefit in breast cancer surgery trial

NCT ID NCT03216187

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether the drug pregabalin could prevent persistent pain in women at high risk after breast cancer surgery. It included 126 patients who were given either pregabalin or a placebo before and after surgery. The trial was stopped early, and the results did not show a clear benefit in reducing long-term pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

126 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 physical activity) * Suicidal ideation, identified by the question: "have you been bothered by thoughts that you would be better off dead, or of killing yourself?" * Planned fertility preservation immediately after surgery before a planned chemotherapy * Known or suspected non-compliance, or substance-use disorder with impact on medication adherence

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brustzentrum Bern

    Bern, Switzerland

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, 1011, Switzerland

  • Clinique de Genolier

    Genolier, 1272, Switzerland

  • Clinique des Grangettes

    Geneva, Switzerland

  • Hôpitaux Universitaires de Genève HUG

    Geneva, 1211, Switzerland

  • Inselspital

    Bern, 3010, Switzerland

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