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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
| University of California, San Diego | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Cephalon |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Armodafinil |
|
| Group 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armodafinil | Drug | Taken orally once a day in the morning. Dose will change depending upon level of fatigue |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quality of Life at Days 22, 43 and 56 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eudocia Lee, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD San Diego | La Jolla | California | United States | |||
| Beth Israel Deaconess Medical Center |
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Randomization was performed by the Quality Assurance for Clinical Trials office at the Dana Farber Cancer Institute. Patients were randomized in a 1:1 basis to each treatment arm with no stratification.
Study activated at Dana-Farber Cancer Institute in August 2008 and was eventually activated at Beth Israel Medical Center , Dartmouth Hitchcock Medical Center, and University of California San Diego. The study closed to new accrual as of April 2014 as the accrual was met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil | Armodafinil: 150mg taken orally once a day in the morning. |
| FG001 | Placebo | Placebo: Taken orally once a day in the morning |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil | Armodafinil: Taken orally once a day in the morning. |
| BG001 | Placebo | Placebo: Taken orally once a day in the morning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received. | Posted | Median | 80% Confidence Interval | units on a scale | 43 days |
Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact.
Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Armodafinil | Armodafinil: Taken orally once a day in the morning. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eudocia Quant Lee, MD | Dana-Farber Cancer Insitute | 617-632-2166 | eqlee@partners.org |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| INDUSTRY |
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| Placebo | Other | Placebo taken once a day in the morning |
|
| baseline, day 22, day 43, and day 56 |
| Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment | To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment. | 56 days |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Protocol Violation |
|
| Tumor Progression on Study |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Karnofsky Performance Status (KPS) | Karnofsky Performance Status ranges from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease) in increments of 10. This was measured at baseline, prior to any treatment on study. | Median | Full Range | Units on a scale |
|
| Glioma grade | Glioma is a broad category of brain and spinal cord. Gliomas can be grade I, II, III or IV. For the purposes of this study, Grade II, III, and IV were eligible for enrollment. | Number | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Armodafinil | Armodafinil: Taken orally once a day in the morning. |
| OG001 | Placebo | Placebo: Taken orally once a day in the morning. |
|
|
|
| Secondary | Change From Baseline in Quality of Life at Days 22, 43 and 56 | 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. | Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received. | Posted | Median | 80% Confidence Interval | units on a scale | baseline, day 22, day 43, and day 56 |
|
|
|
| Secondary | Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment | To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment. | Grade 3 - 4 events at least possibly related to study treatment. | Posted | Number | number of incidents | 56 days |
|
|
|
| 3 |
| 42 |
| 36 |
| 42 |
| EG001 | Placebo | Placebo: Taken orally once a day in the morning. | 5 | 39 | 33 | 39 |
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Obstruction, Cecum | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hearing w/o audiogr not in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Otitis, external ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hearing-other | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Myelodysplasia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Heart block Wolff-Parkinson-White | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cardiac-other | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Constitutional, other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Coagulation-other | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cushingnoid appearance | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Teeth development | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection w/ gr3-4 neut, oral cavity | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection Gr0-2 neut, oral cavity | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection Gr0-2 neut, paranasal | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| nfection Gr0-2 neut, urinary tract | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| nfection Gr0-2 neut, wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection w/ unk ANC skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema head and neck | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Edema limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| ALT, SGPT | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| AST, SGOT | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypercalcemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypoglycemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Lipase | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Metabolic/Laboratory-other | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nonneuropathic lower extr muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nonneuropathic upper extr muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nonneuropathic left-side muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| CNS necrosis/cystic progression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neuropathy CN II vision | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neuropathy CN V jaw / face-sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neurologic-other | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Ocular-other | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dental/teeth/peridontal, pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dental/teeth/peridontal, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neck, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain- other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Renal - other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| FACIT-G (baseline vs day 56) |
|
| Dehydration |
|
| Diarrhea |
|
| Glaucoma |
|
| Hyperkalemia |
|
| Hypokalemia |
|
| Hypomagnesemia |
|
| Ileus |
|
| Insomnia |
|
| Mood alteration (agitation) |
|
| Obstruction, cecum |
|
| Rash |
|
| Seizure |
|
| Speech impairment |
|