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


Phase 2
21 Years
75 Years
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UPCC 19108

NCT ID:

NCT01019187

Start Date:

June 2009

Completion Date:

June 2013

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283