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OpenTrials
Completed

NCT Number: NCT00630695

Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

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

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Key information

Conditions

Lymphocele Cysts Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Mère Enfant- CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide LP 90

Drug

Lanreotide LP 90

Placebo lanreotide

Drug

Placebo

Primary outcomes

  1. Quantity of lymph collected by the drain

    Time frame: D4 post operativly

Secondary outcomes

  1. Prevention of lymphocele

    Time frame: D15, D30 and M6

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Ipsen

Registry information

Official study title

Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2008
Registry last updated
Jan 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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