Management of Insomnia in Breast Cancer Patients

NCT01011218 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB-17323K07CA132916-01A125740BRS0008
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Fatigue

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  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.

  up to 32 Weeks

Secondary Outcomes (1)

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

  up to 32 Weeks

Other Outcomes (2)

• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  up to 32 Weeks

• Brief Fatigue Inventory (BFI)

  up to 32 Weeks

Study Arms (4)

BBT-I + Armodafinil

EXPERIMENTAL

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; Drug: Armodafinil

Behavioral placebo + Armodafinil

EXPERIMENTAL

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

Behavioral: Control; Drug: Armodafinil

BBT-I without Armodafinil

SHAM COMPARATOR

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

Behavioral placebo without Armodafinil

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

BBT-I BEHAVIORAL

Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone

Also known as: Brief Behavioral Intervention for Insomnia

BBT-I + Armodafinil; BBT-I without Armodafinil

Control BEHAVIORAL

Control behavioral intervention is a sleep hygiene handout completed by participant.

Also known as: Behavioral placebo

Behavioral placebo + Armodafinil; Behavioral placebo without Armodafinil

Armodafinil DRUG

150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.

Also known as: Nuvigil

BBT-I + Armodafinil; Behavioral placebo + Armodafinil

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Females with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Oxana RG Palesh, MD, PhD; Assistant Professor of Psychiatry and Behavioral Sciences
• Organization: Stanford University Medical Center

oxana.palesh@stanford.edu

650-725-7011

Study Officials

• Oxana RG Palesh, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: January 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 29, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)