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A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

This study has been completed.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
University of California, San Diego
Beth Israel Deaconess Medical Center
Cephalon
Information provided by (Responsible Party):
Eudocia Quant Lee, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier:
NCT00766467
First received: October 2, 2008
Last updated: June 17, 2016
Last verified: June 2016
  Purpose
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.

Condition Intervention Phase
Malignant Glioma
Drug: Armodafinil
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Change From Baseline in Fatigue at Day 43 [ Time Frame: 43 days ] [ Designated as safety issue: No ]
    The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.


Secondary Outcome Measures:
  • Change From Baseline in Quality of Life at Days 22, 43 and 56 [ Time Frame: baseline, day 22, day 43, and day 56 ] [ Designated as safety issue: No ]
    The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.

  • Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.


Enrollment: 81
Study Start Date: September 2008
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Armodafinil
Drug: Armodafinil
Taken orally once a day in the morning. Dose will change depending upon level of fatigue
Other Name: Nuvigil
Placebo Comparator: Group 2
Placebo
Other: Placebo
Placebo taken once a day in the morning

Detailed Description:
  • Since no one knows for certain if armodafinil improves fatigue in brain tumor patients undergoing radiation therapy, participants will be randomized into one of two study groups. Half of the participants will receive armodafinil and the other half will receive pills with no medicine (placebo). Neither the participant or the study doctor will know what group they are in.
  • Participants will be given a study medication-dosing calendar and will take either the study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days 8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days from the radiation start date.
  • Participants will be evaluated via documented clinician telephone call and self-administered questionnaires on days 1, 8, 22, 43 and 57.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also eligible
  • Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving hyperfractionated radiotherapy are also eligible
  • KPS of 70% or greater
  • Electrolytes within normal institutional limits: BUN and Creatinine < 2.5 x ULN: AST, ALT, Bilirubin < 2.5 x ULN
  • Able to swallow medication

Exclusion Criteria:

  • History of recent cardiac arrhythmia or unstable angina
  • Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within the past 30 days
  • Clinically significant untreated sleep apnea
  • A history of clinically significant cardiac disease, including a history of recent myocardial infarction, history of unstable angina, history of left ventricular hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)
  • Uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, narcolepsy, clinically significant untreated sleep apnea, psychotic disorder or Tourette's syndrome
  • Patients taking warfarin for anticoagulation are eligible, but monitoring of prothrombin times is suggested as a precaution
  • Hemoglobin level of less then 11 g/dl
  • Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood greater than 5.0 mlU/L
  • Current treatment or history of psychotic disorder, bipolar disorder, or anxiety disorder
  • Patients with a score of > 28 on the Beck depression inventory consistent with severe depression
  • Known hypersensitivity to armodafinil or related compounds
  • Patients who have been receiving MAO inhibitors during the past 14 days
  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: NCT00766467

Locations
United States, California
UCSD San Diego
La Jolla, California, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Eudocia Quant Lee, MD
Dartmouth-Hitchcock Medical Center
University of California, San Diego
Beth Israel Deaconess Medical Center
Cephalon
Investigators
Principal Investigator: Eudocia Lee, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Eudocia Quant Lee, MD, Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier: NCT00766467     History of Changes
Other Study ID Numbers: 07-341 
Study First Received: October 2, 2008
Results First Received: March 4, 2016
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
armodafinil
Nuvigil
fatigue

Additional relevant MeSH terms:
Glioma
Fatigue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016