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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01019187
First received: November 13, 2009
Last updated: February 26, 2013
Last verified: February 2013

November 13, 2009
February 26, 2013
June 2009
June 2013   (final data collection date for primary outcome measure)
  • Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. [ Designated as safety issue: No ]
  • Fatigue as assessed by the brief fatigue index [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Mid-point and end of treatment ] [ Designated as safety issue: Yes ]
  • Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries. [ Time Frame: N?A ] [ Designated as safety issue: No ]
  • Fatigue as assessed by the brief fatigue index [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Mid-point and end of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01019187 on ClinicalTrials.gov Archive Site
  • Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue [ Designated as safety issue: No ]
  • Sleep latency, wake after sleep onset, and total sleep time [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Unspecified Adult Solid Tumor, Protocol Specific
  • 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
    Other Name: sleep disorder therapy
  • Procedure: cognitive assessment
  • Procedure: Quality of Life assessment
    Ancillary Studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Fatigue assessment and management
    Other Name: 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
226
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
21 Years to 75 Years
No
Contact: Michael Perlis 855-216-0098 hbarilla@exchange.upenn.edu
United States
 
NCT01019187
UPCC 19108
Not Provided
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
February 2013

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