Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00178373
First received: September 12, 2005
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.

The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.


Condition Intervention Phase
Cancer
Fatigue
Chemotherapy
Drug: Modafinil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • degree to which modafinil can reduce patient fatigue following treatment for cancer [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cytokine blood levels [ Designated as safety issue: No ]
  • depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D) [ Designated as safety issue: No ]
  • cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment [ Designated as safety issue: No ]
  • psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC) [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil
Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
Drug: Modafinil
Placebo Comparator: placebo
Inactive sugar pill, 2 are taken once a day in the morning

Detailed Description:

Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:

  1. better control of the fatigue reported by patients during and following cancer treatment is needed,
  2. there are few systematic data on the etiology of fatigue following cancer treatment, and
  3. there is evidence indicating that chemotherapy is associated with cognitive dysfunction.

Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.

The primary objective is to:

  • compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks

Secondary objectives are to:

  • assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
  • assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
  • investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction

Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
  • Patient is 18 years of age or older
  • Patient is able to swallow medication
  • Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater

Exclusion Criteria:

  • Patient has ever taken modafinil (PROVIGIL)
  • Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)
  • Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
  • Patient presently taking on a regular basis:

    • an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
    • alpha-interferon or interleukin-2,
    • a corticosteroid (dexamethasone, prednisone, prednisolone)
  • Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
  • Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
  • Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178373

Locations
United States, New York
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Cephalon
Investigators
Principal Investigator: Gary R. Morrow, Ph.D., M.S. University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642
  More Information

No publications provided

Responsible Party: Gary Morrow, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00178373     History of Changes
Other Study ID Numbers: U2702
Study First Received: September 12, 2005
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
cancer-related fatigue
chemotherapy
modafinil

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014