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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00052286
First received: January 24, 2003
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Fatigue
Drug: modafinil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Neurocognitive functioning [ Time Frame: at baseline and weeks 1, 3, 4, 8, and 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: September 2002
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00052286

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-6967
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Timothy F. Cloughesy, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00052286     History of Changes
Other Study ID Numbers: CDR0000258139, P30CA016042, UCLA-0206017, CEPHALON-UCLA-0206017, NCI-G02-2133
Study First Received: January 24, 2003
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
adult brain tumor
fatigue
cognitive/functional effects

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

ClinicalTrials.gov processed this record on October 22, 2014