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

April 6, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed DescriptionOBJECTIVES:

I. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, reduce insomnia in cancer patients following the conclusion of chemotherapy and/or radiation therapy.

II. To determine if one or more of the intervention strategies (i.e, CBT-I, armodafinil, or both), when compared to a placebo only group, reduce fatigue in cancer patients following the conclusion of chemotherapy and/or radiation therapy.

III. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, improve QOL in cancer patients following the conclusion of chemotherapy and/or radiation therapy.

OUTLINE: Patients are randomized to 1 of 4 treatment arms (cognitive behavioral therapy, armodafinil, both, or neither).

After completion of study treatment, patients are followed for 30 days.

Study Type

Interventional

Enrollment (Anticipated)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm I
Patients receive oral placebo twice daily for 47 days.
Other: Questionnaire Administration
Ancillary studies
Other: Questionnaire Administration
Ancillary Studies
Other: Placebo
Given orally
Other Names:
  • PLCB
Procedure: Quality-of-Life Assessment
Ancillary Studies
Procedure: Fatigue Assessment and Management
Other Names:
  • Fatigue Assessment and Mangement
Experimental: Arm II
Patients receive oral armodafinil twice daily for 47 days.
Other: Questionnaire Administration
Ancillary studies
Other: Questionnaire Administration
Ancillary Studies
Procedure: Quality-of-life assessment
Ancillary studies
Other Names:
  • Quality of Life assessment
Drug: Armodafinil
Given orally
Other Names:
  • Nuvigil
Procedure: Fatigue Assessment and Management
Other Names:
  • Fatigue Assessment and Mangement
Procedure: Sleep Disorder Therapy
Other Names:
  • Sleep disorders therapy
Procedure: Management of Therapy
Other Names:
  • Complications of therapy management
Experimental: Arm III
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: cognitive assessment
Other: Questionnaire Administration
Ancillary Studies
Other: Placebo
Given orally
Other Names:
  • PLCB
Procedure: Sleep disorder therapy
Other Names:
  • sleep disorders therapy
Procedure: Quality of Life assessment
Ancillary Studies
Procedure: Fatigue assessment and management
Procedure: Management of therapy and complications
Other Names:
  • Compllications of therapy management
Experimental: Arm IV
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Questionnaire Administration
Ancillary Studies
Drug: Armodafinil
Given orally
Other Names:
  • Nuvigil
Procedure: Sleep disorder therapy
Other Names:
  • sleep disorders therapy
Procedure: Cognitive Assessment
Procedure: Quality of Life Assessment
Quality of Life Assessment
Other Names:
  • Ancillary studies
Procedure: Fatifue assessment and management
Other Names:
  • Fatigue Assessment/management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Fatigue as assessed by the brief fatigue index
Adverse Events
Time Frame: Mid-point and end of treatment
Mid-point and end of treatment

Secondary Outcome Measures

Outcome Measure
Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
Sleep latency, wake after sleep onset, and total sleep time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Michael Perlis, MD, Abramson Cancer Center of The University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 24, 2009

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 19108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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