Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042848
• Other study ID #: CDR0000069477
• Secondary ID: U10CA037420URCC-
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2002
• Last updated: October 13, 2015
• Start date: August 2002
• Est. completion date: October 2007

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 837
• Est. completion date: October 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• modafinil

Locations

Country	Name	City	State
United States	Medical Center of Aurora - South Campus	Aurora	Colorado
United States	Boulder Community Hospital	Boulder	Colorado
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	Rocky Mountain Cancer Centers - Denver Rose	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Swedish Medical Center	Englewood	Colorado
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers - Longmont	Longmont	Colorado
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	CCOP - Metro-Minnesota	St. Louis Park	Minnesota
United States	CCOP - Northwest	Tacoma	Washington
United States	Rocky Mountain Cancer Centers - Thornton	Thornton	Colorado
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary	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