Overview

This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments quality-of-life assessment, questionnaire administration, placebo, fatigue assessment and management, sleep disorder therapy, armodafinil, management of therapy, cognitive assessment, quality of life assessment, management of therapy and complications, fatifue assessment and management
Phase phase 2
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date June 2009
End date August 2013
Trial size 226 participants
Trial identifier NCT01019187, UPCC 19108

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Placebo Comparator)
Patients receive oral placebo twice daily for 47 days.
quality-of-life assessment
Ancillary Studies
questionnaire administration
Ancillary Studies
placebo PLCB
Given orally
fatigue assessment and management Fatigue Assessment/Management
(Experimental)
Patients receive oral armodafinil twice daily for 47 days.
sleep disorder therapy Sleep disorders therapy
armodafinil Nuvigil
Given orally
quality-of-life assessment Quality of Life assessment
Ancillary studies
questionnaire administration
Ancillary Studies
fatigue assessment and management Fatigue Assessment and Mangement
management of therapy Complications of therapy management
(Experimental)
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.
sleep disorder therapy
cognitive assessment
quality of life assessment
Ancillary Studies
questionnaire administration
Ancillary studies
placebo PLCB
Given orally
fatigue assessment and management
management of therapy and complications Compllications of therapy management
(Experimental)
Patients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
sleep disorder therapy sleep disorders therapy
armodafinil Nuvigil
Given orally
cognitive assessment
quality of life assessment Ancillary studies
Quality of Life Assessment
questionnaire administration
Ancillary Studies
fatifue assessment and management Fatigue Assessment/management

Primary Outcomes

Measure
Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
time frame:
Fatigue as assessed by the brief fatigue index
time frame:
Adverse Events
time frame: Mid-point and end of treatment

Secondary Outcomes

Measure
Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
time frame:
Sleep latency, wake after sleep onset, and total sleep time
time frame:

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Principal investigator Michael Perlis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.