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Management of Insomnia in Breast Cancer Patients

2014-08-27 03:18:04 | BioPortfolio

Summary

Primary Objective:

1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients receiving chemotherapy.

Secondary Objectives:

1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on cancer-related fatigue (CRF) in breast cancer patients receiving chemotherapy.

2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy.

3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in combination) on endocrine and inflammatory physiological markers (measured by cortisol and inflammatory cytokines markers)

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Insomnia

Intervention

Armodafinil, Brief Behavioral Intervention for Insomnia, Placebo

Location

University of Rochester
Rochester
New York
United States
14642

Status

Recruiting

Source

University of Rochester

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:04-0400

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