Cognitive/Functional EffectsNCT00112515
Modafinil in Treating Fatigue in Patients With Cancer
A study testing modafinil, cognitive assessment and psychosocial assessment and care in people with Cognitive/Functional Effects and Depression, run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer. PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive/Functional Effects, Depression, Fatigue
- What is being tested?
- modafinil, cognitive assessment and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to not given
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Brief Fatigue Inventory score ≥ 4
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 1-3
Life expectancy
- At least 2 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No history of left ventricular hypertrophy
- No history of ischemic ECG changes
- No history of chest pain
- No history of arrhythmia
- No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use
Other
- Not pregnant or nursing
- Negative pregnancy test
- Thyroid stimulating hormone normal
- No known hypersensitivity to modafinil
- No history of psychotic disorder and/or active psychosis
- No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent thalidomide allowed
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Concurrent narcotics, phenothiazines, or benzodiazepines allowed
- No other concurrent investigational therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.
PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of modafinil in cancer patients.
- Determine the efficacy of this drug, in terms of improving fatigue, in these patients.
Secondary
- Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.
OUTLINE: This is a nonrandomized, pilot study.
Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.
Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.
- Conditions
- Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- modafinil, cognitive assessment, psychosocial assessment and care, quality-of-life assessment
- Keywords
- depression, cognitive/functional effects, fatigue, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
cognitive assessmentProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary outcomes (8)
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Leslie Blackhall, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112515
- Sponsor's protocol ID
- CDR0000432953
- Other IDs
- UVACC-HIC-10951, UVACC-30603
- Status last verified
- May 2006
- First submitted
- 2 Jun 2005
- Last updated
- 20 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
- ClinicalTrials.gov ID
- NCT00112515
- Acronym / sponsor ID
- CDR0000432953
- Conditions
- Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- depression, cognitive/functional effects, fatigue, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- First posted
- 3 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.
PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of modafinil in cancer patients.
- Determine the efficacy of this drug, in terms of improving fatigue, in these patients.
Secondary
- Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.
OUTLINE: This is a nonrandomized, pilot study.
Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.
Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modafinil | Drug | – |
| cognitive assessment | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
8 secondary outcomes
Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Blackhall, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modafinil, cognitive assessment and psychosocial assessment and care in people with Cognitive/Functional Effects and Depression, run by University of Virginia 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?
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: status not confirmed, as of the sponsor's last update on 20 Aug 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2009.