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”

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.

Intervention(s) in this Clinical Trial

• Procedure: Quality-of-Life Assessment
  • Ancillary Studies
• Other: Questionnaire Administration
  • Ancillary Studies
• Other: Placebo
  • Given orally
• Procedure: Fatigue Assessment and Management
• Procedure: Sleep Disorder Therapy
• Drug: Armodafinil
  • Given orally
• Procedure: Quality-of-life assessment
  • Ancillary studies
• Other: Questionnaire Administration
  • Ancillary Studies
• Procedure: Fatigue Assessment and Management
• Procedure: Management of Therapy
• Procedure: Sleep disorder therapy
• Procedure: cognitive assessment
• Procedure: Quality of Life assessment
  • Ancillary Studies
• Other: Questionnaire Administration
  • Ancillary studies
• Other: Placebo
  • Given orally
• Procedure: Fatigue assessment and management
• Procedure: Management of therapy and complications
• Procedure: Sleep disorder therapy
• Drug: Armodafinil
  • Given orally
• Procedure: Cognitive Assessment
• Procedure: Quality of Life Assessment
  • Quality of Life Assessment
• Other: Questionnaire Administration
  • Ancillary Studies
• Procedure: Fatifue assessment and management

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm I
  • Patients receive oral placebo twice daily for 47 days.
• Experimental: Arm II
  • Patients receive oral armodafinil twice daily for 47 days.
• 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.
• 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.

Primary Measures

• Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
  • Safety Issue?: No
• Fatigue as assessed by the brief fatigue index
  • Safety Issue?: No
• Adverse Events
  • Time Frame: Mid-point and end of treatment
    Safety Issue?: Yes

Secondary Measures

• Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
  • Safety Issue?: No
• Sleep latency, wake after sleep onset, and total sleep time
  • Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abramson Cancer Center of the University of Pennsylvania Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Michael Perlis  hbarilla@exchange.upenn.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019187

Study ID Number: UPCC 19108

ClinicalTrials.gov Identifier: NCT01019187

Health Authority: United States: Institutional Review Board