Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pasireotide LAR Administration in Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

NCT01356862

Breast Cancer

COMPLETED PHASE2

Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea

NCT01754285

Lymphorrhea

COMPLETED PHASE2

Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

NCT03791736

Breast Cancer Lymphocele

TERMINATED NA

Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

NCT00932035

Breast Cancer

TERMINATED PHASE1/PHASE2

Medico-economic Study of Three Strategies of Sentinel Lymph Node Analysis in Operable Breast Cancer

NCT02056886

Breast Cancer Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.

Data will be compared in the 2 groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphocele

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lanreotide LP 90

Group Type EXPERIMENTAL

Lanreotide LP 90

Intervention Type DRUG

Lanreotide LP 90

2

Group Type PLACEBO_COMPARATOR

Placebo lanreotide

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lanreotide LP 90

Intervention Type DRUG

Placebo lanreotide

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patient (\> 18 years),
* Patient undergoing an axillary lymphadenectomy for breast cancer
* Patient giving her agreement after being informed

Exclusion Criteria

* Patients that don't understand the trial
* Type 2 diabetic patients
* Cyclosporine treatment
* Biliary lithiasis
* Pregnancy or breast feeding
* Allergic reaction to Lanréotide or same class treatments
* Patient included in another trial within the last 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No