A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Phase III Study of Armodafinil for the Treatment of Cancer-Related Fatigue for Patients With Multiple Myeloma|
- BFI Score [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
- Trail Making Test B Score (TMT-B) [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]
Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.
The test evaluates the time to correctly order letters and numbers; low times = better performance.
- Symbol Digit Modalities Test Score (SDMT) [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance
- Digit Span Test Score [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.
- Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).
- Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.
- Epworth Sleepiness Scale (ESS) Score [ Time Frame: Day 1, Day 28 and Day 56 ] [ Designated as safety issue: No ]Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness
|Study Start Date:||June 2010|
|Study Completion Date:||May 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Other Name: Nuvigil
Placebo Comparator: Placebo-First
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Other Name: NuvigilDrug: Placebo
Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
Other Name: sugar-pill
This is a Phase III, multi-center, double-blind, randomized, placebo-controlled, crossover study to evaluate the efficacy of armodafinil at a dosage of 150 mg/day for the treatment of cancer-related fatigue (CRF) in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56 day treatment phase, and a final assessment to occur 28 days after the end of the last treatment.
The screening period will occur within 14 days before baseline, where "baseline" refers to day 1 when assessments will be made before drug administration. During this period, a medical history will be obtained along with a complete physical examination including vital sign measurements and Eastern Cooperative Oncology Group (ECOG) performance status. Clinical laboratory tests including hematology, clinical chemistry (blood urea nitrogen [BUN], serum creatinine, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), electrolytes (potassium, sodium, chloride and calcium), random glucose, total protein, albumin, and urinalysis will also be performed during the screening period as well as serum pregnancy tests for women of childbearing potential.
During the screening period, patients will also be assessed for the presence of cancer-related fatigue using the International Classification for Disease Tenth Edition (ICD-10) diagnostic criteria and the Brief Fatigue Inventory (BFI). Only those patients showing evidence of cancer-related fatigue will be enrolled in the study. The criteria for inclusion for any given patient consist of meeting the International Classification for Disease Tenth Edition (ICD-10) criteria for cancer-related fatigue and a score ≥ 4 on the BFI. ICD-10 CRF classification will be established using a standard interview guide.
Patients eligible for the study will be randomized to either receive armodafinil at an initial fixed dosage of 150 mg/day (Group A) or a placebo (Group B) during the first 28 days of the treatment phase. On day 29, patients randomized to receive placebo will then cross over to receive armodafinil at a dosage of 150 mg/day until day 56. Group A patients randomized to receive armodafinil will continue their current treatment with the drug until day 56. The duration of the treatment phase is 56 days.
Assessments for CRF will be conducted on day 1 (baseline) prior to drug treatment, and after drug administration on days 15, 28, 43, and 56. These assessments will be conducted as verbal interviews, paper-and-pencil surveys, paper-and-pencil tests, and electronic tests as appropriate per assessment.
During the treatment phase, each patient will also have clinical laboratory tests performed on days 1, 15, 28, 43 and 56 to monitor for potential toxicity. Additional procedures performed at these visits will include monitoring for adverse events, review of concomitant medications and other support therapies (e.g., growth factors and transfusion), ECOG performance status, vital signs measurements, and physical examinations.
Twenty-eight days after the last dose of study drug, patients are to complete a final assessment (herein referred to as the end-of-treatment visit). Procedures to be conducted at this visit include measurement of vital signs, a complete physical examination, assessment of adverse events, a review of concomitant medications, assessment of ECOG performance status, hematology and clinical chemistry laboratory tests including electrolytes, total protein and albumin. Patients who withdraw from the study before the completion of the 56 day cycle will still have all end-of-treatment assessments performed 28 days after their last dose of study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160380
|United States, California|
|Pacific Cancer Medical Center, Inc.|
|Anaheim, California, United States, 92801|
|Michael J. Schlutz, M.D., Inc|
|Newport Beach, California, United States, 92663|
|James R. Berenson, MD, Inc.|
|West Hollywood, California, United States, 90069|
|Principal Investigator:||James Berenson, MD||James R. Berenson MD, Inc.|