Management of Insomnia in Breast Cancer Patients

Stanford University

Status and phase: Completed; Phase 2

Conditions: Insomnia; Fatigue

Treatments: Behavioral: Control; Behavioral: BBT-I; Drug: Armodafinil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01011218

25740 (Other Identifier)

BRS0008 (Other Identifier)

IRB-17323

K07CA132916-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 4 patient groups, including a placebo group

BBT-I + Armodafinil

Experimental group

Description:

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.

Treatment:

Drug: Armodafinil

Behavioral: BBT-I

Behavioral placebo + Armodafinil

Experimental group

Description:

Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.

Treatment:

Drug: Armodafinil

Behavioral: Control

BBT-I without Armodafinil

Sham Comparator group

Description:

Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention.

Treatment:

Behavioral: BBT-I

Behavioral placebo without Armodafinil

Placebo Comparator group

Description:

Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention.

Treatment:

Behavioral: Control