Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

NCT01091974 | Completed Phase 2 Results DMC

• 2 other identifiers: UCCS070901R01CA126968-01A1
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Conditions

Insomnia; Fatigue; Breast Cancer

Keywords

Insomnia; Fatigue; QOL; CBT; Breast cancer; Survivors; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index From Baseline to Post-intervention

  The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.

  ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Secondary Outcomes (1)

• Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

  ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Study Arms (4)

1 - CBT-I + placebo

EXPERIMENTAL

CBT-I and placebo

Drug: Placebo Comparator; Behavioral: CBT-I

2 - CBT-I + Armodafinil

EXPERIMENTAL

CBT-I + Armodafinil

Drug: armodafinil; Behavioral: CBT-I

3 - Placebo only

PLACEBO COMPARATOR

Placebo only

Drug: Placebo Comparator

4 - Armodafinil only

EXPERIMENTAL

Armodafinil only

Drug: armodafinil

Interventions

armodafinil DRUG

Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

2 - CBT-I + Armodafinil; 4 - Armodafinil only

Placebo Comparator DRUG

Placebo for 47 days

1 - CBT-I + placebo; 3 - Placebo only

CBT-I BEHAVIORAL

Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

1 - CBT-I + placebo; 2 - CBT-I + Armodafinil

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of cancer.
• Be able to understand written and spoken English
• Be able to swallow medication
• Have preferred sleep phase between 7:30 pm and 11:00 am
• Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period
• Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
• Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
• Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.)
• Report insomnia on the SDS-CL at a frequency of at least 3 days a week

You may not qualify if:

• Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component.
• Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years)
• Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
• Be presently taking an anticoagulant or a corticosteroid
• Have taken amphetamines (e.g., methylphenidate, pemoline \[Cylert®\] or similar psycho stimulants) within the past 30 days
• Be currently pregnant or nursing
• Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score \>=2 or an Alcohol Use Disorders Identification Test (AUDIT) score \>=13
• Have surgery planned within the study period
• Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Rochester James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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

• Peoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors. J Clin Sleep Med. 2019 Jan 15;15(1):129-137. doi: 10.5664/jcsm.7586.

  PMID: 30621831 DERIVED

• Roscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015 Jan 10;33(2):165-71. doi: 10.1200/JCO.2014.57.6769. Epub 2014 Dec 1.

  PMID: 25452447 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue; Breast Neoplasms

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; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joseph A. Roscoe Ph.D.
• Organization: University of Rochester Medical Center

Joseph_Roscoe@URMC.Rochester.edu

(585) 275-9962

Study Officials

• Joseph A Roscoe, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: March 24, 2010
• Study Start: February 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 9, 2017
• Results First Posted: March 13, 2015

Record last verified: 2016-12

Locations

US (2)