Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

July 30, 2020 updated by: Jonsson Comprehensive Cancer Center

A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients

RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.

PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
  • Determine the safety of this drug in these patients.
  • Compare quality of life of patients treated with 2 different doses of this drug.

OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.

  • Randomized phase:

    • Arm I: Patients receive oral high-dose modafinil twice daily.
    • Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
  • Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.

Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-6967
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
  • Nonmalignant cerebral tumors also allowed
  • Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
  • Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale
  • Age 21 to 65
  • Able to speak English
  • Capable of completing self-rating scales and one-on-one psychometric tests
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed
  • Concurrent glucocorticoids (e.g., dexamethasone) allowed
  • Concurrent tamoxifen allowed
  • At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
  • Concurrent anticonvulsants allowed
  • Concurrent isotretinoin allowed

Exclusion Criteria:

  • Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal.
  • Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl.
  • severe cognitive impairment
  • other terminal illness
  • emergency patient
  • institutional resident
  • prisoner or parolee
  • UCLA students or staff
  • pregnant or nursing
  • concurrent irinotecan
  • concurrent participation in UCLA experimental chemotherapy trials
  • prior modafinil
  • concurrent experimental anticancer medication
  • concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug dosage 1
- Arm I: Patients receive oral high-dose modafinil twice daily.
Drug: modafinil
Experimental: drug dosage 2
- Arm II: Patients receive oral low-dose modafinil twice daily.
Drug: modafinil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurocognitive functioning
Time Frame: at baseline and weeks 1, 3, 4, 8, and 10
at baseline and weeks 1, 3, 4, 8, and 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change.
Time Frame: at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000258139
  • UCLA-0206017
  • CEPHALON-UCLA-0206017
  • NCI-G02-2133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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