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Trial record 97 of 241 for:    (armodafinil)

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

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ClinicalTrials.gov Identifier: NCT01019187
Recruitment Status : Unknown
Verified January 2017 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2009
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 13, 2009
First Posted Date  ICMJE November 24, 2009
Last Update Posted Date January 25, 2017
Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2009)
  • Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. [ Time Frame: N?A ]
  • Fatigue as assessed by the brief fatigue index
  • Adverse Events [ Time Frame: Mid-point and end of treatment ]
Change History Complete list of historical versions of study NCT01019187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2009)
  • Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
  • Sleep latency, wake after sleep onset, and total sleep time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
Official Title  ICMJE Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Procedure: Quality-of-Life Assessment
    Ancillary Studies
  • Other: Questionnaire Administration
    Ancillary Studies
  • Other: Placebo
    Given orally
    Other Name: PLCB
  • Procedure: Fatigue Assessment and Management
    Other Name: Fatigue Assessment/Management
  • Procedure: Sleep Disorder Therapy
    Other Name: Sleep disorders therapy
  • Drug: Armodafinil
    Given orally
    Other Name: Nuvigil
  • Procedure: Quality-of-life assessment
    Ancillary studies
    Other Name: Quality of Life assessment
  • Procedure: Fatigue Assessment and Management
    Other Name: Fatigue Assessment and Mangement
  • Procedure: Management of Therapy
    Other Name: Complications of therapy management
  • Procedure: Sleep disorder therapy
  • Procedure: cognitive assessment
  • Procedure: Quality of Life assessment
    Ancillary Studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Fatigue assessment and management
  • Procedure: Management of therapy and complications
    Other Name: Compllications of therapy management
  • Procedure: Sleep disorder therapy
    Other Name: sleep disorders therapy
  • Procedure: Cognitive Assessment
  • Procedure: Quality of Life Assessment
    Quality of Life Assessment
    Other Name: Ancillary studies
  • Procedure: Fatifue assessment and management
    Other Name: Fatigue Assessment/management
Study Arms  ICMJE
  • Placebo Comparator: Arm I
    Patients receive oral placebo twice daily for 47 days.
    Interventions:
    • Procedure: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Placebo
    • Procedure: Fatigue Assessment and Management
  • Experimental: Arm II
    Patients receive oral armodafinil twice daily for 47 days.
    Interventions:
    • Procedure: Sleep Disorder Therapy
    • Drug: Armodafinil
    • Procedure: Quality-of-life assessment
    • Other: Questionnaire Administration
    • Procedure: Fatigue Assessment and Management
    • Procedure: Management of Therapy
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • Procedure: Sleep disorder therapy
    • Drug: Armodafinil
    • Procedure: Cognitive Assessment
    • Procedure: Quality of Life Assessment
    • Other: Questionnaire Administration
    • Procedure: Fatifue assessment and management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2009)
226
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01019187
Other Study ID Numbers  ICMJE UPCC 19108
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Perlis, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP