Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019187
• Other study ID #: UPCC 19108
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: August 2015

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: August 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• Quality-of-Life Assessment
Ancillary Studies

Other:
• Questionnaire Administration
Ancillary Studies
• Placebo
Given orally

Procedure:
• Fatigue Assessment and Management

• Sleep Disorder Therapy

Drug:
• Armodafinil
Given orally

Procedure:
• Quality-of-life assessment
Ancillary studies

Other:
• Questionnaire Administration
Ancillary Studies

Procedure:
• Fatigue Assessment and Management

• Management of Therapy

• Sleep disorder therapy

• cognitive assessment

• Quality of Life assessment
Ancillary Studies

Other:
• Questionnaire Administration
Ancillary studies
• Placebo
Given orally

Procedure:
• Fatigue assessment and management

• Management of therapy and complications

• Sleep disorder therapy

Drug:
• Armodafinil
Given orally

Procedure:
• Cognitive Assessment

• Quality of Life Assessment
Quality of Life Assessment

Other:
• Questionnaire Administration
Ancillary Studies

Procedure:
• Fatifue assessment and management

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.
Primary	Fatigue as assessed by the brief fatigue index
Primary	Adverse Events		Mid-point and end of treatment
Secondary	Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue
Secondary	Sleep latency, wake after sleep onset, and total sleep time