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

NCT00766467 | Completed Phase 2 Results DMC

• 1 other identifier: 07-341
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Malignant Glioma

Keywords

armodafinil; Nuvigil; fatigue

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Fatigue at Day 43

  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.

  43 days

Secondary Outcomes (2)

• Change From Baseline in Quality of Life at Days 22, 43 and 56

  baseline, day 22, day 43, and day 56

• Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment

  56 days

Study Arms (2)

Group 1

EXPERIMENTAL

Armodafinil

Drug: Armodafinil

Group 2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Armodafinil DRUG

Taken orally once a day in the morning. Dose will change depending upon level of fatigue

Also known as: Nuvigil

Group 1

Placebo OTHER

Placebo taken once a day in the morning

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eudocia Quant Lee, MD: lead
• Dartmouth-Hitchcock Medical Center: collaborator
• University of California, San Diego: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Cephalon: collaborator

Study Sites (4)

UCSD San Diego

La Jolla, California, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Glioma; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Eudocia Quant Lee, MD
• Organization: Dana-Farber Cancer Insitute

eqlee@partners.org

617-632-2166

Study Officials

• Eudocia Lee, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Center for Neuro-Oncology

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 6, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 28, 2016
• Results First Posted: July 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)