Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2002

Last Updated Date

October 13, 2015

Start Date ^ICMJE

August 2002

Primary Completion Date

April 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00042848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Official Title ^ICMJE

Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care

Condition ^ICMJE

Fatigue
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: modafinil

Study Arms

Not Provided

Publications *

Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

837

Completion Date

October 2007

Primary Completion Date

April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 120 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00042848

Other Study ID Numbers ^ICMJE

CDR0000069477
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-U2901 ( Other Identifier: University of Rochester )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Gary Morrow, University of Rochester NCORP Research Base

Study Sponsor ^ICMJE

Gary Morrow

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Gary R. Morrow, PhD, MS

James P. Wilmot Cancer Center

PRS Account

University of Rochester

Verification Date

October 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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