CancerPhase 2NCT00178373
Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
A Phase 2 study testing Modafinil and sugar pill in people with Cancer and Fatigue, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Fatigue, Chemotherapy
- What is being tested?
- Modafinil and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
- Patient is 18 years of age or older
- Patient is able to swallow medication
- Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater
Who cannot join
- Patient has ever taken modafinil (PROVIGIL)
- Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)
- Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
- Patient presently taking on a regular basis:
- an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
- alpha-interferon or interleukin-2,
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- a corticosteroid (dexamethasone, prednisone, prednisolone)
- Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
- Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
- Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, 14642
About this study
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.
The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.
Read the detailed description
Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:
- better control of the fatigue reported by patients during and following cancer treatment is needed,
- there are few systematic data on the etiology of fatigue following cancer treatment, and
- there is evidence indicating that chemotherapy is associated with cognitive dysfunction.
Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.
The primary objective is to:
- compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks
Secondary objectives are to:
- assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
- assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
- investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction
Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.
- Conditions
- Cancer, Fatigue, Chemotherapy
- Being tested
- Modafinil, sugar pill
- Keywords
- cancer-related fatigue, chemotherapy, modafinil
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Experimental | Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning. Receives: Drug: Modafinil |
| placebo | Placebo comparator | Inactive sugar pill, 2 are taken once a day in the morning Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree to which modafinil can reduce patient fatigue following treatment for cancer
Measured: 4 weeks
Secondary outcomes (4)
cytokine blood levels
depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D)
cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment
psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionDec 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Principal investigator, Gary Morrow, University of Rochester
- Investigators
- Gary R. Morrow, Ph.D., M.S., Principal investigator, University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178373
- Sponsor's protocol ID
- U2702
- Status last verified
- Dec 2015
- First submitted
- 12 Sep 2005
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
- ClinicalTrials.gov ID
- NCT00178373
- Acronym / sponsor ID
- U2702
- Conditions
- Cancer, Fatigue, Chemotherapy
- Keywords
- cancer-related fatigue, chemotherapy, modafinil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- May 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 15 Sep 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.
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.
The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.
Detailed description
Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:
- better control of the fatigue reported by patients during and following cancer treatment is needed,
- there are few systematic data on the etiology of fatigue following cancer treatment, and
- there is evidence indicating that chemotherapy is associated with cognitive dysfunction.
Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.
The primary objective is to:
- compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks
Secondary objectives are to:
- assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
- assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
- investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction
Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modafinil | Experimental | Drug: ModafinilModafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning. |
| placebo | Placebo comparator | Drug: sugar pillInactive sugar pill, 2 are taken once a day in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
- Patient is 18 years of age or older
- Patient is able to swallow medication
- Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater
Key exclusion criteria (10 listed)
- Patient has ever taken modafinil (PROVIGIL)
- Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)
- Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
- Patient presently taking on a regular basis:
- Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
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 | Modafinil |
| sugar pill | Drug | placebo |
Primary outcome
degree to which modafinil can reduce patient fatigue following treatment for cancer
Time frame: 4 weeks
4 secondary outcomes
cytokine blood levels
depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D)
cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment
psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
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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.
Gary R. Morrow, Ph.D., M.S. principal investigator
University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modafinil and sugar pill in people with Cancer and Fatigue, run by University of Rochester 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 4 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 23 Dec 2015. 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?
degree to which modafinil can reduce patient fatigue following treatment for cancer (time frame: 4 weeks). 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 23 Dec 2015.