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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

Brief Summary:

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele. According to the literature, incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is inserted or a compression dressing applied and the time at which the drain is removed… In our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients between November 2008 and February 2009]

Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using Octreotide have been recorded in two recent studies. A new molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)

The purpose of this trial is to assess the efficacy of a pre-surgical injection of pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following axillary node dissection.

The secondary objectives are to assess the efficacy of prolonged release pasireotide on the duration of postoperative drainage, the daily drainage volume, the total drainage volume, the number of repeated lymphocele aspirations and the volume, the total volume of lymph aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of prolonged release pasireotide.

The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the i

Detailed Summary:

Octreotide, a somatostatin analog, has demonstrated its efficacy in the medical management of postoperative gastro-intestinal and pancreatic fistulae. Two recent studies have shown its value in reducing lymphoceles following axillary node dissection performed as part of breast cancer surgery.

The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the postoperative development of lymphocele following the removal of an axillary drain. This may be a source of pain, repeated aspiration, infection and delayed local healing.

Pasireotide, a somatostatin analog under evaluation and possessing a high affinity for somatostatine receptors (30 to 40 times greater for sst1 and sst5 receptors, 5 times greater for sst3 and equivalent for sst2) is an attractive molecule in this indication.

Based on the encouraging results published with octreotide and the greater effects anticipated with pasireotide, the investigators want to assess the benefit of preoperative administration of pasireotide in reducing the incidence of axillary lymphoceles following mastectomy - axillary node dissection.

Somatostatin is a hormone that is widely distributed in the nervous and gastropancreatic system responsible for a variety of pharmacological and physiological effects. It can inhibit gastrointestinal endocrine and exocrine secretion and has an anti-inflammatory action (1). The direct effect of somatostatin on lymphatic flow has only been observed on the gastrointestinal tract.

Several series report the use of octreotide in the treatment of chylous ascites or in the management of thoracic duct injury (2). Although its mechanism of action has not been studied in
Sponsor: Alliance Pour La Recherche en Cancerologie

Current Primary Outcome: aspirations global volume of lymphoceles [ Time Frame: 1 to 32 days after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alliance Pour La Recherche en Cancerologie

Dates:
Date Received: May 18, 2011
Date Started: September 2010
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017