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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01019187
Collaborator
(none)
226
Enrollment
1
Location
4
Arms
74
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Placebo
  • Procedure: Fatigue Assessment and Management
  • Procedure: Sleep Disorder Therapy
  • Drug: Armodafinil
  • Procedure: Quality-of-life assessment
  • Other: Questionnaire Administration
  • Procedure: Fatigue Assessment and Management
  • Procedure: Management of Therapy
  • 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
  • Procedure: Sleep disorder therapy
  • Drug: Armodafinil
  • Procedure: Cognitive Assessment
  • Procedure: Quality of Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Fatifue assessment and management
 Phase 2

Detailed Description

Detailed DescriptionOBJECTIVES:

  1. 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.

  2. 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.

  3. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
226 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm I

Patients receive oral placebo twice daily for 47 days.

Procedure: Quality-of-Life Assessment
Ancillary Studies

Other: Questionnaire Administration
Ancillary Studies

Other: Placebo
Given orally
Other Names:
  • PLCB

    • Procedure: Fatigue Assessment and Management
    Other Names:
  • Fatigue Assessment/Management

    		•
    Experimental: Arm II

    Patients receive oral armodafinil twice daily for 47 days.

    Procedure: Sleep Disorder Therapy
    Other Names:
  • Sleep disorders therapy

    • Drug: Armodafinil
    Given orally
    Other Names:
  • Nuvigil

    • Procedure: Quality-of-life assessment
    Ancillary studies
    Other Names:
  • Quality of Life assessment

    • Other: Questionnaire Administration
    Ancillary Studies

    Procedure: Fatigue Assessment and Management
    Other Names:
  • Fatigue Assessment and Mangement

    • 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.

    Procedure: Sleep disorder therapy

    Procedure: cognitive assessment

    Procedure: Quality of Life assessment
    Ancillary Studies

    Other: Questionnaire Administration
    Ancillary studies

    Other: Placebo
    Given orally
    Other Names:
  • PLCB

    • 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.

    Procedure: Sleep disorder therapy
    Other Names:
  • sleep disorders therapy

    • Drug: Armodafinil
    Given orally
    Other Names:
  • Nuvigil

    • Procedure: Cognitive Assessment

    Procedure: Quality of Life Assessment
    Quality of Life Assessment
    Other Names:
  • Ancillary studies

    • Other: Questionnaire Administration
    Ancillary Studies

    Procedure: Fatifue assessment and management
    Other Names:
  • Fatigue Assessment/management

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. []

    2. Fatigue as assessed by the brief fatigue index []

    3. Adverse Events [Mid-point and end of treatment]

    Secondary Outcome Measures

    1. Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue []

    2. Sleep latency, wake after sleep onset, and total sleep time []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01019187
    Other Study ID Numbers:
    • UPCC 19108
    First Posted:
    Nov 24, 2009
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Fatigue
    Modafinil

    Study Results

    No Results Posted as of Apr 9, 2020