Clinical trial NCT00042848: Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Official title: Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Mobile
country: United States
facility: MBCCOP - Gulf Coast
state: Alabama
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Santa Rosa
country: United States
facility: CCOP - Santa Rosa Memorial Hospital
state: California
city: Aurora
country: United States
facility: Medical Center of Aurora - South Campus
state: Colorado
city: Boulder
country: United States
facility: Boulder Community Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Penrose Cancer Center at Penrose Hospital
state: Colorado
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Denver
country: United States
facility: St. Joseph Hospital
state: Colorado
city: Denver
country: United States
facility: Presbyterian - St. Luke's Medical Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver Rose
state: Colorado
city: Denver
country: United States
facility: CCOP - Colorado Cancer Research Program
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Lone Tree
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers - Longmont
state: Colorado
city: Pueblo
country: United States
facility: St. Mary-Corwin Regional Medical Center
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers - Thornton
state: Colorado
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Chicago
country: United States
facility: MBCCOP - University of Illinois at Chicago
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: St. Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: East Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Seattle
country: United States
facility: CCOP - Virginia Mason Research Center
state: Washington
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: James P. Wilmot Cancer Center
name: Gary R. Morrow, PhD, MS
role: STUDY_CHAIR
References:
citation: 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.