Management of Insomnia in Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01011218 |
Recruitment Status :
Completed
First Posted : November 11, 2009
Results First Posted : October 9, 2018
Last Update Posted : November 29, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insomnia Fatigue | Behavioral: BBT-I Behavioral: Control Drug: Armodafinil | Phase 2 |
The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.
Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.
Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.
Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: BBT-I + Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. |
Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Name: Brief Behavioral Intervention for Insomnia Drug: Armodafinil 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Name: Nuvigil |
Experimental: Behavioral placebo + Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. |
Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Name: Behavioral placebo Drug: Armodafinil 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Name: Nuvigil |
Sham Comparator: BBT-I without Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. |
Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Name: Brief Behavioral Intervention for Insomnia |
Placebo Comparator: Behavioral placebo without Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. |
Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Name: Behavioral placebo |
- Insomnia Severity Index (ISI) [ Time Frame: up to 32 Weeks ]
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows.
- 0 to 7 No clinically significant insomnia
- 8 to14 Subthreshold insomnia
- 15 to 21 Clinical insomnia (moderate severity)
- 22 to 28 Clinical insomnia (severe)
ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: up to 32 Weeks ]
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.
The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
- The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: up to 32 Weeks ]
The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.
The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
- Brief Fatigue Inventory (BFI) [ Time Frame: up to 32 Weeks ]
The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue.
The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Females with breast cancer |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011218
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
Principal Investigator: | Oxana RG Palesh, PhD, MPH | Stanford University |
Responsible Party: | Oxana Palesh, Assistant Professor of Psychiatry and Behavioral Sciences, Stanford University |
ClinicalTrials.gov Identifier: | NCT01011218 |
Other Study ID Numbers: |
IRB-17323 K07CA132916-01A1 ( U.S. NIH Grant/Contract ) 25740 ( Other Identifier: University of Rochester - old protocol ID ) BRS0008 ( Other Identifier: OnCore ) |
First Posted: | November 11, 2009 Key Record Dates |
Results First Posted: | October 9, 2018 |
Last Update Posted: | November 29, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Modafinil |
Central Nervous System Stimulants Physiological Effects of Drugs Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |