NCT00052286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 3, 2020

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

January 24, 2003

Last Update Submit

July 30, 2020

Conditions

Brain and Central Nervous System TumorsCognitive/Functional EffectsFatigue

Keywords

adult brain tumorfatiguecognitive/functional effects

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive functioning

    at baseline and weeks 1, 3, 4, 8, and 10

Secondary Outcomes (1)

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

    at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Study Arms (2)

drug dosage 1

EXPERIMENTAL

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

Drug: modafinil

drug dosage 2

EXPERIMENTAL

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

Drug: modafinil

Interventions

modafinilDRUG
drug dosage 1drug dosage 2

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-6967, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsFatigueBrain Neoplasms

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Timothy F. Cloughesy, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

July 1, 2006

Study Completion

August 1, 2010

Last Updated

August 3, 2020

Record last verified: 2016-02

Locations

US(1)