Clinical trial NCT01019187: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-24
Enrollment: 226
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
measure: Fatigue as assessed by the brief fatigue index
measure: Adverse Events
timeFrame: Mid-point and end of treatment
Secondary outcomes:
measure: Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
measure: Sleep latency, wake after sleep onset, and total sleep time
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Michael Perlis, MD
role: PRINCIPAL_INVESTIGATOR
References: