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Unspecified Adult Solid Tumor, Protocol SpecificPhase 2NCT01019187

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

A Phase 2 study testing Quality-of-Life Assessment, Questionnaire Administration and Fatigue Assessment and Management in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 75 years
What is being tested?
Quality-of-Life Assessment, Questionnaire Administration and Fatigue Assessment and Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
1 siteUnited States
Study dates
Jun 2009to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the detailed description

Detailed DescriptionOBJECTIVES:

  1. 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.

Being tested
Quality-of-Life Assessment, Questionnaire Administration, Placebo, Fatigue Assessment and Management, Sleep Disorder Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentProcedure or surgery

    Ancillary Studies

  • Questionnaire AdministrationOther

    Ancillary Studies

  • PlaceboOther

    Also called PLCB

    Given orally

  • Fatigue Assessment and ManagementProcedure or surgery

    Also called Fatigue Assessment/Management

  • Sleep Disorder TherapyProcedure or surgery

    Also called Sleep disorders therapy

  • ArmodafinilDrug

    Also called Nuvigil

    Given orally

  • Quality-of-life assessmentProcedure or surgery

    Also called Quality of Life assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary Studies

  • Fatigue Assessment and ManagementProcedure or surgery

    Also called Fatigue Assessment and Mangement

  • Management of TherapyProcedure or surgery

    Also called Complications of therapy management

  • Sleep disorder therapyProcedure or surgery

  • cognitive assessmentProcedure or surgery

  • Quality of Life assessmentProcedure or surgery

    Ancillary Studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • PlaceboOther

    Also called PLCB

    Given orally

  • Fatigue assessment and managementProcedure or surgery

  • Management of therapy and complicationsProcedure or surgery

    Also called Compllications of therapy management

  • Sleep disorder therapyProcedure or surgery

    Also called sleep disorders therapy

  • ArmodafinilDrug

    Also called Nuvigil

    Given orally

  • Cognitive AssessmentProcedure or surgery

  • Quality of Life AssessmentProcedure or surgery

    Also called Ancillary studies

    Quality of Life Assessment

  • Questionnaire AdministrationOther

    Ancillary Studies

  • Fatifue assessment and managementProcedure or surgery

    Also called Fatigue Assessment/management

Study groups in NCT01019187
Study groupRoleWhat they receive
Arm IPlacebo comparatorPatients receive oral placebo twice daily for 47 days.
Receives: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Placebo; Procedure: Fatigue Assessment and Management
Arm IIExperimentalPatients receive oral armodafinil twice daily for 47 days.
Receives: Procedure: Sleep Disorder Therapy; Drug: Armodafinil; Procedure: Quality-of-life assessment; Other: Questionnaire Administration; Procedure: Fatigue Assessment and Management; Procedure: Management of Therapy
Arm IIIExperimentalPatients 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.
Receives: Procedure: Sleep disorder therapy; Procedure: cognitive assessment; Procedure: Quality of Life assessment; Other: Questionnaire Administration; Other: Placebo; Procedure: Fatigue assessment and management; Procedure: Management of therapy and complications
Arm IVExperimentalPatients receive oral armodafinil twice daily for 47 days. Patients undergo cognitive behavioral therapy for insomnia as in Arm III for 7 weeks.
Receives: Procedure: Sleep disorder therapy; Drug: Armodafinil; Procedure: Cognitive Assessment; Procedure: Quality of Life Assessment; Other: Questionnaire Administration; Procedure: Fatifue assessment and management

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Fatigue as assessed by the brief fatigue index

  3. Adverse Events

    Measured: Mid-point and end of treatment

Secondary outcomes (2)

  1. Fatigue as assessed by the functional assessment of chronic illness therapy-fatigue

  2. Sleep latency, wake after sleep onset, and total sleep time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionAug 2013
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01019187
Sponsor's protocol ID
UPCC 19108
Status last verified
Apr 2020
First submitted
13 Nov 2009
Last updated
9 Apr 2020
Results posted
No

Publications

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PubMed 41170811

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quality-of-Life Assessment, Questionnaire Administration and Fatigue Assessment and Management in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of insomnia as assessed by the insomnia severity index and daily sleeep diaries.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01019187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.

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