Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

NCT01019187 | Completed Phase 2

• 1 other identifier: UPCC 19108
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.

• Fatigue as assessed by the brief fatigue index

• Adverse Events

  Mid-point and end of treatment

Secondary Outcomes (2)

• Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue

• Sleep latency, wake after sleep onset, and total sleep time

Study Arms (4)

Arm I

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 47 days.

Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Placebo; Procedure: Fatigue Assessment and Management

Arm II

EXPERIMENTAL

Patients receive oral armodafinil twice daily for 47 days.

Procedure: Sleep Disorder Therapy; Drug: Armodafinil; Procedure: Quality-of-life assessment; Other: Questionnaire Administration; Procedure: Fatigue Assessment and Management; Procedure: Management of Therapy

Arm III

EXPERIMENTAL

Patients receive oral placebo twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia comprising sleep restriction therapy, stimulus control instruction, sleep hygiene guidelines, and a session of cognitive therapy for 7 weeks.

Procedure: Sleep disorder therapy; Procedure: cognitive assessment; Procedure: Quality of Life assessment; Other: Questionnaire Administration; Other: Placebo; Procedure: Fatigue assessment and management; Procedure: Management of therapy and complications

Arm IV

EXPERIMENTAL

Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.

Procedure: Sleep disorder therapy; Drug: Armodafinil; Procedure: Cognitive Assessment; Procedure: Quality of Life Assessment; Other: Questionnaire Administration; Procedure: Fatifue assessment and management

Interventions

Quality-of-life assessment PROCEDURE

Ancillary Studies

Arm I

Questionnaire Administration OTHER

Ancillary Studies

Arm I

Placebo OTHER

Given orally

Also known as: PLCB

Arm I

Fatigue assessment and management PROCEDURE

Also known as: Fatigue Assessment/Management

Arm I

Sleep disorder therapy PROCEDURE

Also known as: Sleep disorders therapy

Arm II

Armodafinil DRUG

Given orally

Also known as: Nuvigil

Arm II

Management of Therapy PROCEDURE

Also known as: Complications of therapy management

Arm II

Cognitive Assessment PROCEDURE

Arm III

Quality of Life Assessment PROCEDURE

Ancillary Studies

Arm III

Management of therapy and complications PROCEDURE

Also known as: Compllications of therapy management

Arm III

Fatifue assessment and management PROCEDURE

Also known as: Fatigue Assessment/management

Arm IV

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
• At least one month must have passed since completion of chemotherapy and/or radiation treatment
• 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 armodafinil 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 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
• Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the "Frequently" level

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, 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

Interventions

Therapeutics; Modafinil; Medication Therapy Management; Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Michael Perlis, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 24, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2015
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

US (1)