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Unspecified Adult Solid Tumor, Protocol Specific | Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Unspecified Adult Solid Tumor, Protocol Specific

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Quality-of-Life AssessmentAncillary Studies

Other:Questionnaire AdministrationAncillary Studies

Other:PlaceboGiven orally

Procedure:Fatigue Assessment and Management

Procedure:Sleep Disorder Therapy

Drug:ArmodafinilGiven orally

Procedure:Quality-of-life assessmentAncillary studies

Other:Questionnaire AdministrationAncillary Studies

Procedure:Fatigue Assessment and Management

Procedure:Management of Therapy

Procedure:Sleep disorder therapy

Procedure:cognitive assessment

Procedure:Quality of Life assessmentAncillary Studies

Other:Questionnaire AdministrationAncillary studies

Other:PlaceboGiven orally

Procedure:Fatigue assessment and management

Procedure:Management of therapy and complications

Procedure:Sleep disorder therapy

Drug:ArmodafinilGiven orally

Procedure:Cognitive Assessment

Procedure:Quality of Life AssessmentQuality of Life Assessment

Other:Questionnaire AdministrationAncillary Studies

Procedure:Fatifue assessment and management

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm IPatients receive oral placebo twice daily for 47 days.

Arm IIPatients receive oral armodafinil twice daily for 47 days.

Arm IIIPatients 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.

Arm IVPatients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.

Study Status

Active, not recruiting

Start Date: June 2009

Completed Date:

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.

Secondary Outcome: Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue

Study sponsors, principal investigator, and references

Principal Investigator: Michael Perlis, MD

Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01019187

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