search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
modafinil
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring adult brain tumor, fatigue, cognitive/functional effects

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

drug dosage 1

drug dosage 2

Arm Description

- Arm I: Patients receive oral high-dose modafinil twice daily.

- Arm II: Patients receive oral low-dose modafinil twice daily.

Outcomes

Primary Outcome Measures

Neurocognitive functioning

Secondary Outcome Measures

Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change.

Full Information

First Posted
January 24, 2003
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Cephalon
search

1. Study Identification

Unique Protocol Identification Number
NCT00052286
Brief Title
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Official Title
A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue
Keywords
adult brain tumor, fatigue, cognitive/functional effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug dosage 1
Arm Type
Experimental
Arm Description
- Arm I: Patients receive oral high-dose modafinil twice daily.
Arm Title
drug dosage 2
Arm Type
Experimental
Arm Description
- Arm II: Patients receive oral low-dose modafinil twice daily.
Intervention Type
Drug
Intervention Name(s)
modafinil
Primary Outcome Measure Information:
Title
Neurocognitive functioning
Time Frame
at baseline and weeks 1, 3, 4, 8, and 10
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy F. Cloughesy, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6967
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs