Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
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| ClinicalTrials.gov Identifier: NCT00042848 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 15, 2015
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RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known.
PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fatigue Unspecified Adult Solid Tumor, Protocol Specific | Drug: modafinil | Phase 3 |
OBJECTIVES:
- Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy.
- Assess the relationship between depression and fatigue in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily.
- Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral placebo once daily.
Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity.
Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy.
PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within approximately 2.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 837 participants |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Supportive Care |
| Official Title: | Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy |
| Study Start Date : | August 2002 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | October 2007 |
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
- Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
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Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy
- Each course of chemotherapy must be at least 2 weeks in duration
- No concurrent radiotherapy or interferon therapy
- Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- No uncontrolled anemia
Renal
- Not specified
Cardiovascular
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No history of clinically significant cardiac disease, including any of the following:
- Unstable angina
- Left ventricular hypertrophy
- Ischemic echocardiogram changes
- Chest pain
- Arrhythmia
- Other clinically significant manifestations of mitral valve prolapse in association with use of central nervous system stimulants (e.g., caffeine, amphetamines, or methylphenidate)
- No uncontrolled hypertension
Gastrointestinal
- Able to swallow medication
- No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
Other
- No severe headaches
- No glaucoma
- No seizure disorder
- No narcolepsy
- No psychotic disorder
- No Tourette's syndrome
- No alcohol or drug abuse
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent chronic corticosteroids
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No prior modafinil
- At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)
- No concurrent alcohol
- Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed
- Concurrent phenytoin allowed
- Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042848
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| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
| Responsible Party: | Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base |
| ClinicalTrials.gov Identifier: | NCT00042848 |
| Other Study ID Numbers: |
CDR0000069477 U10CA037420 ( U.S. NIH Grant/Contract ) URCC-U2901 ( Other Identifier: University of Rochester ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | October 15, 2015 |
| Last Verified: | October 2015 |
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fatigue unspecified adult solid tumor, protocol specific |
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Fatigue Modafinil Central Nervous System Stimulants Physiological Effects of Drugs |
Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |