Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

What Was Tested

The trial (phase 3) is built around Lanreotide.

Evaluation of the lymphorrhea in the 2 arms of the study.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Lanreotide LP 90.

The registry classes the interventions as drug.

More on the Plan

Patients will be recruited among patient refered to their 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.

Who Took Part

Enrollment: 148 actual participants took part.

It was open to women only aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patient (\> 18 years),. Patient undergoing an axillary lymphadenectomy for breast cancer. Patient giving her agreement after being informed.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients that don't understand the trial; type 2 diabetic patients; cyclosporine treatment.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Lanreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-03 with completion listed for 2011-06.

It ran at 1 site in France.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Quantity of lymph collected by the drain (time frame: D4 post operativly).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 148 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.