Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Status Recruiting

Clinical Trial Summary

RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- Determine whether the addition of dalteparin results in improved survival.

Secondary

- Determine venous thrombotic event-free survival and metastasis-free survival.

- Determine serious adverse events in patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Determine the quality of life, breathlessness, anxiety, and depression in patients treated with this drug.

- Determine the cost effectiveness and cost utility of this drug.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I (control): Patients receive anticancer treatment considered appropriate by the local medical team.

- Arm II: Patients receive anticancer treatment considered appropriate by the local medical team. Beginning before the start of the first definitive anticancer treatment, patients receive dalteparin subcutaneously daily for up to 24 weeks.

Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24 weeks, and then at 9 and 12 months.

After completion of therapy, patients are followed at 9 months, 1 year, and then every 6 months for at least 2 years. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00519805
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Recruiting
Phase	Phase 3
Start date	August 2007

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