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
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
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
Procedure: Management of Therapy
Procedure: Sleep disorder therapy
Procedure: cognitive assessment
Procedure: Quality of Life assessment
Procedure: Fatigue assessment and management
Procedure: Management of therapy and complications
Procedure: Cognitive Assessment
Procedure: Quality of Life Assessment
Procedure: Fatifue assessment and management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 226
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PLCB
Procedure: Fatigue Assessment and Management
Other Name: Fatigue Assessment/Management
Experimental: Arm II
Patients receive oral armodafinil twice daily for 47 days.
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
Other: Questionnaire Administration
Ancillary Studies
Procedure: Fatigue Assessment and Management
Other Name: Fatigue Assessment and Mangement
Procedure: Management of Therapy
Other Name: 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
Other Name: sleep disorder therapy
Procedure: cognitive assessment 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 and management
Procedure: Management of therapy and complications
Other Name: 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 Name: sleep disorders therapy
Drug: Armodafinil
Given orally
Other Name: Nuvigil
Procedure: Cognitive Assessment Procedure: Quality of Life Assessment
Quality of Life Assessment
Other Name: Ancillary studies
Other: Questionnaire Administration
Ancillary Studies
Procedure: Fatifue assessment and management
Other Name: Fatigue Assessment/management

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019187

Contacts
Contact: Michael Perlis 855-216-0098 hbarilla@exchange.upenn.edu

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Perlis, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01019187     History of Changes
Other Study ID Numbers: UPCC 19108
Study First Received: November 13, 2009
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014