Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
This study has been completed.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00052286
First received: January 24, 2003
Last updated: January 11, 2013
Last verified: January 2013
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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
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: | January 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
adult brain tumor fatigue cognitive/functional effects |
Additional relevant MeSH terms:
|
Fatigue Nervous System Neoplasms Central Nervous System Neoplasms Signs and Symptoms Neoplasms by Site Neoplasms Nervous System Diseases Modafinil |
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013