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

Primary Purpose

Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Placebo
Fatigue Assessment and Management
Sleep Disorder Therapy
Armodafinil
Quality-of-life assessment
Questionnaire Administration
Fatigue Assessment and Management
Management of Therapy
Sleep disorder therapy
cognitive assessment
Quality of Life assessment
Questionnaire Administration
Placebo
Fatigue assessment and management
Management of therapy and complications
Sleep disorder therapy
Armodafinil
Cognitive Assessment
Quality of Life Assessment
Questionnaire Administration
Fatifue assessment and management
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

Patients receive oral placebo twice daily for 47 days.

Patients receive oral armodafinil twice daily for 47 days.

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.

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

Outcomes

Primary Outcome Measures

Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Fatigue as assessed by the brief fatigue index
Adverse Events

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2009
Last Updated
April 6, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01019187
Brief Title
Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
Official Title
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo twice daily for 47 days.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral armodafinil twice daily for 47 days.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm IV
Arm Type
Experimental
Arm Description
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary Studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary Studies
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
Fatigue Assessment and Management
Other Intervention Name(s)
Fatigue Assessment/Management
Intervention Type
Procedure
Intervention Name(s)
Sleep Disorder Therapy
Other Intervention Name(s)
Sleep disorders therapy
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
Quality-of-life assessment
Other Intervention Name(s)
Quality of Life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary Studies
Intervention Type
Procedure
Intervention Name(s)
Fatigue Assessment and Management
Other Intervention Name(s)
Fatigue Assessment and Mangement
Intervention Type
Procedure
Intervention Name(s)
Management of Therapy
Other Intervention Name(s)
Complications of therapy management
Intervention Type
Procedure
Intervention Name(s)
Sleep disorder therapy
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
Quality of Life assessment
Intervention Description
Ancillary Studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
Fatigue assessment and management
Intervention Type
Procedure
Intervention Name(s)
Management of therapy and complications
Other Intervention Name(s)
Compllications of therapy management
Intervention Type
Procedure
Intervention Name(s)
Sleep disorder therapy
Other Intervention Name(s)
sleep disorders therapy
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
Cognitive Assessment
Intervention Type
Procedure
Intervention Name(s)
Quality of Life Assessment
Other Intervention Name(s)
Ancillary studies
Intervention Description
Quality of Life Assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary Studies
Intervention Type
Procedure
Intervention Name(s)
Fatifue assessment and management
Other Intervention Name(s)
Fatigue Assessment/management
Primary Outcome Measure Information:
Title
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Title
Fatigue as assessed by the brief fatigue index
Title
Adverse Events
Time Frame
Mid-point and end of treatment
Secondary Outcome Measure Information:
Title
Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
Title
Sleep latency, wake after sleep onset, and total sleep time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Perlis, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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