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Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
This study has been completed.
Sponsor:
Gary Morrow
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00042848
First received: August 5, 2002
Last updated: October 13, 2015
Last verified: October 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Fatigue Unspecified Adult Solid Tumor, Protocol Specific | Drug: modafinil | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Gary Morrow, University of Rochester NCORP Research Base:
Primary Outcome Measures:
- Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 837 |
| Study Start Date: | August 2002 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
-
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
-
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00042848
Show 35 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042848
Show 35 Study Locations
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
More Information
Publications:
| Responsible Party: | Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base |
| ClinicalTrials.gov Identifier: | NCT00042848 History of Changes |
| Other Study ID Numbers: |
CDR0000069477 U10CA037420 ( U.S. NIH Grant/Contract ) URCC-U2901 ( Other Identifier: University of Rochester ) |
| Study First Received: | August 5, 2002 |
| Last Updated: | October 13, 2015 |
Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
|
fatigue unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Fatigue Signs and Symptoms Modafinil Armodafinil Wakefulness-Promoting Agents |
Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 17, 2017