- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624734
Impact of the Intraoperative Use of Amines in Breast Cancer Surgery on Tumor Recurrence (MASTECTAMINE)
Adrenergic receptors (alpha and beta) are expressed on breast cancer cells, and their stimulation has been shown in experimental studies to promote tumor proliferation and metastasis. Conversely, observational data suggest that beta-blockers may have a protective effect on cancer recurrence. During mastectomy, adrenergic agonists such as catecholamines (e.g., ephedrine, phenylephrine, norepinephrine) and other agents (e.g., clonidine) are frequently used intraoperatively to maintain hemodynamic stability, potentially activating these receptors. While some data suggest that perioperative adrenergic stimulation may influence tumor biology, the clinical impact on cancer recurrence remains unclear.
This retrospective exploratory study aims to evaluate whether the use of adrenergic agents during anesthesia for mastectomy influences tumor recurrence in breast cancer patients. Approximately 250 patients undergoing mastectomy over a 5-year period will be included. The study will assess the association between intraoperative exposure to adrenergic drugs and oncological outcomes, with the goal of better understanding the potential role of perioperative factors in cancer progression.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Hérault
-
Montpellier, Hérault, France, 34000
- CHU Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients operated for a mastectomy for breast cancer
Exclusion Criteria:
- other surgeries for breast cancer not being a mastectomy
- mastectomy for other conditions than cancer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients operated for a mastectomy for cancer
Patients undergoing mastectomy for cancer management (including both adult and pediatric patients).
|
collection of demographic data, key medical history, use of beta-blockers prior to surgery, anesthesia-related data (agents used to maintain anesthesia, regional anesthesia in addition to general anesthesia, intraoperative use of amines), postoperative morphine consumption, survival, and cancer recurrence within 5 years post-surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cancer recurrence
Time Frame: 5 years post-surgery
|
either local recurrence or metastases
|
5 years post-surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bruzzone A, Pinero CP, Castillo LF, Sarappa MG, Rojas P, Lanari C, Luthy IA. Alpha2-adrenoceptor action on cell proliferation and mammary tumour growth in mice. Br J Pharmacol. 2008 Oct;155(4):494-504. doi: 10.1038/bjp.2008.278. Epub 2008 Jul 7.
- Perez Pinero C, Bruzzone A, Sarappa MG, Castillo LF, Luthy IA. Involvement of alpha2- and beta2-adrenoceptors on breast cancer cell proliferation and tumour growth regulation. Br J Pharmacol. 2012 May;166(2):721-36. doi: 10.1111/j.1476-5381.2011.01791.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-11-366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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