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Lymphorrhea clinical trials

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NCT ID: NCT01754285 Completed - Lymphorrhea Clinical Trials

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

Start date: November 2012
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection. Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg. Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows: Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.