Phase 2
Completed N=70
Management of Insomnia in Breast Cancer Patients
Source: ClinicalTrials.gov NCT01011218 ↗Enrolled (actual)
70
Serious AEs
5.7%
Results posted
Oct 2018
Primary outcomePrimary: Insomnia Severity Index (ISI) — 16.3; 14.6; 13.5; 12.1 units on a scale
Summary
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).
Participants will be randomized into 4 groups:
* Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
* Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
* Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
* Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
16.3; 14.6; 13.5; 12.1; 13.0; 10.8 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) |
27.2; 29.1; 29.1; 30.3; 33.5; 29.6 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
- Have at least 6 weeks of treatment remaining
- ≥ 21 years old
- Able to understand written and spoken English
- Able to swallow medication (until amendment omitting armodafinil treatment)
- Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)
EXCLUSION CRITERIA
- Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
- Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
- Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
- Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
- History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
- History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
- Pregnant or nursing
- History of substance abuse or meet criteria for current alcohol abuse or dependence
- History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
- Severe hepatic impairment (until amendment omitting armodafinil treatment)
Data sourced from ClinicalTrials.gov (NCT01011218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.