Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer - Full Text View

Sponsors and Collaborators:	University of Rochester National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042848

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 III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Cancer

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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 and older
Genders Eligible for Study:	Both
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 CNS 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042848

Show 35 Study Locations

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

Study Chair:

Gary R. Morrow, PhD, MS

James P. Wilmot Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069477, URCC-U2901, NCI-5952, NCI-P02-0228
Study First Received:	August 5, 2002
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00042848 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

fatigue
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Signs and Symptoms
Fatigue
Central Nervous System Stimulants
Neuroprotective Agents
Modafinil

Additional relevant MeSH terms:

Signs and Symptoms
Fatigue
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants

Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on September 10, 2009