NCT00951574

Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)

Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,166 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Nadroparin calcium	Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
DRUG	saline solution (placebo)	Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-05-01
• Completion: 2008-07-01
• First posted: 2009-08-04
• Last updated: 2012-02-01

Locations

46 sites across 1 country: Italy