Overview

This trial is active, not recruiting.

Conditions insomnia, fatigue
Treatments armodafinil, brief behavioral intervention for insomnia (bbt-i), placebo
Phase phase 2/phase 3
Sponsor Stanford University
Collaborator National Cancer Institute (NCI)
Start date January 2011
End date July 2016
Trial size 64 participants
Trial identifier NCT01011218, 25740, BRS0008, IRB-17323, K07CA132916-01A1

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
2 Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone
brief behavioral intervention for insomnia (bbt-i) BBT-I
2 sessions in person and additional brief sessions over the phone
(Experimental)
150 mg once a day
armodafinil Nuvigil
150 mg once a day
(Experimental)
2 BBT-I sessions in person and additional brief BBT-I sessions over the phone + 150 mg Armodafinil once a day
armodafinil Nuvigil
150 mg once a day
brief behavioral intervention for insomnia (bbt-i) BBT-I
2 sessions in person and additional brief sessions over the phone
(Placebo Comparator)
Placebo for Armodafinil
placebo Simulated medical intervention
Placebo pill

Primary Outcomes

Measure
Insomnia Severity Index (ISI)
time frame: 6 months

Secondary Outcomes

Measure
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
time frame: 6 months
Brief Fatigue Inventory
time frame: 6 months

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Be scheduled for planned cancer treatment with chemotherapy or biologics, such as Herceptin (prior chemotherapy and diagnosis of metastatic breast are allowed) - Have at least 6 weeks of treatment remaining - Be at least 21 years old - Be able to swallow medication - Exhibit onset or worsening of problems falling or staying asleep Exclusion Criteria: - Have ever taken armodafinil or modafinil - Have an unstable medical or psychiatric illness (Axis I - current or within the last 5 years) - Have a history of or uncontrolled cardiac disease, hypertension, severe headaches, glaucoma, or seizures - Have taken a psycho-stimulant medication within the past 28 days - Be currently pregnant or nursing - Have a history of substance abuse or meet criteria for current alcohol abuse or dependence - Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS syndrome - Have taken sleep medication daily for the last 28 days continuously - Have severe hepatic impairment - Be taking anti-seizure medications

Additional Information

Official title Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Principal investigator Oxana RG Palesh, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stanford University.