Pain prevention drug fails to prove benefit in breast cancer surgery trial
NCT ID NCT03216187
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?