Fatigue, Multiple Myeloma
Conditions
Keywords
cancer related fatigue, fatigue, multiple myeloma, cancer, quality of life
Brief summary
The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of cancer-related fatigue 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.
Detailed description
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.
Interventions
DRUGarmodafinil
Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
DRUGPlacebo
Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
Sponsors
Cephalon
Oncotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has been diagnosed with multiple myeloma based on standard criteria * The patient is diagnosed with cancer-related fatigue based on ICD-10 diagnostic criteria * The patient shows signs of severe fatigue as evidenced by a Brief Fatigue Inventory score of at least 4 * The patient is a man or woman aged 18 years or older at the time of informed consent * The patient has given voluntary written informed consent before any study-related procedure is performed which is not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care * Women of child bearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. * Men must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug * The patient must be willing and able to comply with study restrictions * The patient must have an ECOG performance status not greater than 2 * The patient must have a life-expectancy of greater than 3 months * The patient must meet the following laboratory criteria within 14 days of enrollment: * Platelet count greater than 50 x 109/L * Absolute neutrophil count greater than 0.5 x 109/L * Hemoglobin greater than 8 g/dL * AST and ALT not greater than 3.0 x the upper limit of normal (ULN) * Serum bilirubin not greater than 2.0 x ULN * Calculated or measured creatinine clearance of at least 10 mL/minute
Exclusion criteria
* The patient has been concurrently diagnosed with clinically significant depression * The patient is concurrently enrolled in another investigational study that does not apply to the specific treatment of multiple myeloma * The patient is receiving an investigational agent (non-FDA-approved) for any reason within 28 days of starting treatment on this study * The patient has previously received armodafinil * The patient has received modafinil or a psychostimulant within 14 days of enrollment * The patient has received a blood transfusion within 14 days of enrollment * The patient has impaired cardiac function or clinically significant cardiac diseases * The patient has other concurrent severe and/or uncontrolled medical or psychiatric conditions including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol * The patient has known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required * The patient has undergone major surgery within 28 days of enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a patient with a recent history of kyphoplasty with Oncotherapeutics' medical monitor) * The patient has a significant history of noncompliance to medical regimens or unwilling or unable to comply with the instructions given to him or her by the study staff * The patient has a history of skin reactions and/or known sensitivity attributable to compounds of similar chemical or biological composition to modafinil, armodafinil, or the inactive ingredients in armodafinil including lactose monohydrate, starch, microcrystalline cellulose, croscarmellose, sodium, magnesium stearate or povidone * The patient is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study * The patient is male whose sexual partner is a woman of childbearing potential not using effective birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BFI Score | Day 1, Day 28 and Day 56 | 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) | Day 1, Day 28 and Day 56 | 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) | Day 1, Day 28 and Day 56 | 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 | Day 1, Day 28 and Day 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) Score | Day 1, Day 28 and Day 56 | 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 | Day 1, Day 28 and Day 56 | 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 |
| Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Day 1, Day 28 and Day 56 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Armodafinil The patients receive armodafinil for all 56 days of the study.
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets. | 25 |
| 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: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Armodafinil | Placebo-First |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 2.1 | 63 years STANDARD_DEVIATION 1.8 | 67 years STANDARD_DEVIATION 2.3 |
| ECOG (Eastern Cooperative Oncology Group) 0 | 12 paarticipants | 5 paarticipants | 7 paarticipants |
| ECOG (Eastern Cooperative Oncology Group) 1 | 35 paarticipants | 18 paarticipants | 17 paarticipants |
| ECOG (Eastern Cooperative Oncology Group) 2 | 3 paarticipants | 2 paarticipants | 1 paarticipants |
| Fatigue (baseline)-Brief Fatigue Inventory (BFI) | 60 units on a scale | 59 units on a scale | 60.5 units on a scale |
| Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10) | 9 units on a scale | 9 units on a scale | 9 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 37 Participants | 17 Participants | 20 Participants |
| Sex: Female, Male Female | 29 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Male | 21 Participants | 11 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 50 | 2 / 25 |
| serious Total, serious adverse events | 2 / 50 | 0 / 25 |
Outcome results
Primary
BFI Score
Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | BFI Score | Day 1(n=18, 23) | 65.0 units on a scale | Standard Deviation 13.2 |
| Armodafinil | BFI Score | Day 28 (n=19, 23) | 48.8 units on a scale | Standard Deviation 22.4 |
| Armodafinil | BFI Score | Day 56 (n=15) | 43.2 units on a scale | Standard Deviation 18.9 |
| Placebo-First | BFI Score | Day 1(n=18, 23) | 57.2 units on a scale | Standard Deviation 14.3 |
| Placebo-First | BFI Score | Day 28 (n=19, 23) | 41.5 units on a scale | Standard Deviation 18.4 |
| Placebo-First | BFI Score | Day 56 (n=15) | NA units on a scale | — |
Comparison: Comparison between Day 1 and Day 28p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Comparison between Day 1 and day 28p-value: <0.002Wilcoxon (Mann-Whitney)
Comparison: Comparison between Day 28 and Day 56 of treatment for the armodafinil armp-value: 0.449t-test, 2 sided
Comparison: Comparison between arms at Day 28 of treatmentp-value: 0.289Wilcoxon (Mann-Whitney)
Primary
Digit Span Test Score
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.
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Digit Span Test Score | Backward-Day 1 (n=18, 23) | 7.3 Number of correct items | Standard Deviation 2 |
| Armodafinil | Digit Span Test Score | Backward- Day 28 (n=19, 23) | 7.0 Number of correct items | Standard Deviation 2.6 |
| Armodafinil | Digit Span Test Score | Forward-Day 1 (n=18, 23) | 9.5 Number of correct items | Standard Deviation 2.7 |
| Armodafinil | Digit Span Test Score | Forward-Day 56 (n=15) | 10.3 Number of correct items | Standard Deviation 2.8 |
| Armodafinil | Digit Span Test Score | Forward-Day 28 (n=19, 23) | 10.6 Number of correct items | Standard Deviation 3 |
| Armodafinil | Digit Span Test Score | Backward-Day 56 (n=15) | 7.4 Number of correct items | Standard Deviation 2.8 |
| Placebo-First | Digit Span Test Score | Backward-Day 56 (n=15) | NA Number of correct items | — |
| Placebo-First | Digit Span Test Score | Forward-Day 1 (n=18, 23) | 9.8 Number of correct items | Standard Deviation 2.6 |
| Placebo-First | Digit Span Test Score | Backward-Day 1 (n=18, 23) | 6.3 Number of correct items | Standard Deviation 2.4 |
| Placebo-First | Digit Span Test Score | Forward-Day 28 (n=19, 23) | 10.4 Number of correct items | Standard Deviation 2.3 |
| Placebo-First | Digit Span Test Score | Backward- Day 28 (n=19, 23) | 7.0 Number of correct items | Standard Deviation 2.6 |
| Placebo-First | Digit Span Test Score | Forward-Day 56 (n=15) | NA Number of correct items | — |
Comparison: Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward testp-value: 0.636Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward testp-value: 0.531Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward testp-value: 0.037Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward testp-value: 0.656t-test, 2 sided
Comparison: Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward testp-value: 0.028t-test, 2 sided
Comparison: Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward testp-value: 0.805t-test, 2 sided
Comparison: Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward testp-value: 0.692t-test, 2 sided
Comparison: Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward testp-value: 0.863t-test, 2 sided
Primary
Symbol Digit Modalities Test Score (SDMT)
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
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Symbol Digit Modalities Test Score (SDMT) | Day 1(n=18, 23) | 41.2 Number of correct matches | Standard Deviation 9.2 |
| Armodafinil | Symbol Digit Modalities Test Score (SDMT) | Day 28 (n=19, 23) | 42.4 Number of correct matches | Standard Deviation 12 |
| Armodafinil | Symbol Digit Modalities Test Score (SDMT) | Day 56 (n=15) | 48.7 Number of correct matches | Standard Deviation 12.3 |
| Placebo-First | Symbol Digit Modalities Test Score (SDMT) | Day 1(n=18, 23) | 40.7 Number of correct matches | Standard Deviation 14.7 |
| Placebo-First | Symbol Digit Modalities Test Score (SDMT) | Day 28 (n=19, 23) | 40.8 Number of correct matches | Standard Deviation 14.7 |
| Placebo-First | Symbol Digit Modalities Test Score (SDMT) | Day 56 (n=15) | NA Number of correct matches | — |
Comparison: Comparison between arms at day 28p-value: 0.699t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First armp-value: 0.984t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Armodafinil armp-value: 0.239Wilcoxon (Mann-Whitney)
Comparison: Day 28 vs. Day 56 of treatment for the Armodafinil armp-value: 0.089t-test, 2 sided
Primary
Trail Making Test B Score (TMT-B)
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.
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Trail Making Test B Score (TMT-B) | Day 1(n=18, 23) | 161.3 seconds | Standard Deviation 77.8 |
| Armodafinil | Trail Making Test B Score (TMT-B) | Day 28 (n=19, 23) | 158.4 seconds | Standard Deviation 81.2 |
| Armodafinil | Trail Making Test B Score (TMT-B) | Day 56 (n=15) | 153.8 seconds | Standard Deviation 78.7 |
| Placebo-First | Trail Making Test B Score (TMT-B) | Day 1(n=18, 23) | 220.5 seconds | Standard Deviation 163.2 |
| Placebo-First | Trail Making Test B Score (TMT-B) | Day 28 (n=19, 23) | 159.8 seconds | Standard Deviation 94.2 |
| Placebo-First | Trail Making Test B Score (TMT-B) | Day 56 (n=15) | NA seconds | — |
Comparison: Comparison between arms at Day 28 of treatmentp-value: 0.954Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First armp-value: 0.007Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Armodafinil armp-value: 0.369Wilcoxon (Mann-Whitney)
Comparison: Comparison between Day 28 and Day 56 of treatment for the Armodafinil armp-value: 0.973t-test, 2 sided
Secondary
Epworth Sleepiness Scale (ESS) Score
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
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Epworth Sleepiness Scale (ESS) Score | Day 1(n=18, 23) | 12.2 units on a scale | Standard Deviation 5.1 |
| Armodafinil | Epworth Sleepiness Scale (ESS) Score | Day 28 (n=19, 23) | 10.1 units on a scale | Standard Deviation 5.1 |
| Armodafinil | Epworth Sleepiness Scale (ESS) Score | Day 56 (n=15) | 11.5 units on a scale | Standard Deviation 4.5 |
| Placebo-First | Epworth Sleepiness Scale (ESS) Score | Day 1(n=18, 23) | 11.5 units on a scale | Standard Deviation 4.5 |
| Placebo-First | Epworth Sleepiness Scale (ESS) Score | Day 28 (n=19, 23) | 10.0 units on a scale | Standard Deviation 4.6 |
| Placebo-First | Epworth Sleepiness Scale (ESS) Score | Day 56 (n=15) | NA units on a scale | — |
Comparison: Comparison between arms for Day 28 of treatment -ESSp-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESSp-value: 0.05t-test, 2 sided
Comparison: Day 1 and Day 28 of treatment for the Armodafinil arm- ESSp-value: 0.051Wilcoxon (Mann-Whitney)
Comparison: Day 28 vs. Day 56 of treatment for the Armodafinil armp-value: 0.635t-test, 2 sided
Secondary
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
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).
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 1 (n=18, 23) | 49.0 units on a scale | Standard Deviation 12.2 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 1 (n=18, 23) | 20.9 units on a scale | Standard Deviation 6.7 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 1 (n=18, 23) | 16.9 units on a scale | Standard Deviation 4.3 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 1 (n=18, 23) | 14.8 units on a scale | Standard Deviation 3.6 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 1 (n=18, 23) | 19.2 units on a scale | Standard Deviation 8.7 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 1 (n=18, 23) | 67.0 units on a scale | Standard Deviation 11.6 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 1 (n=18, 23) | 14.1 units on a scale | Standard Deviation 3.3 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 1 (n=19, 23) | 86.2 units on a scale | Standard Deviation 15.8 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 28 (n=19, 23) | 16.5 units on a scale | Standard Deviation 6.6 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 28 (n=19, 23) | 16.5 units on a scale | Standard Deviation 5.3 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 28 (n=19, 23) | 21.3 units on a scale | Standard Deviation 7.5 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 28 (n=19, 23) | 14.4 units on a scale | Standard Deviation 5.1 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 28 (n=19, 23) | 28.0 units on a scale | Standard Deviation 13.22 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 28 (n=19, 23) | 68.5 units on a scale | Standard Deviation 20.5 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 28 (n=19, 23) | 59.4 units on a scale | Standard Deviation 23.5 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 28 (n=19, 23) | 96.5 units on a scale | Standard Deviation 31.3 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 56 (n=15) | 17.8 units on a scale | Standard Deviation 5.1 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 56 (n=15) | 22.1 units on a scale | Standard Deviation 5.7 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 56 (n=15) | 18.7 units on a scale | Standard Deviation 3.4 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 56 (n=15) | 13.5 units on a scale | Standard Deviation 3.8 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 56 (n=15) | 29.7 units on a scale | Standard Deviation 9.2 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 56 (n=15) | 73.2 units on a scale | Standard Deviation 12.1 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 56 (n=15) | 62.7 units on a scale | Standard Deviation 14.6 |
| Armodafinil | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 56 (n=15) | 101.8 units on a scale | Standard Deviation 18.7 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 1 (n=18, 23) | 15.3 units on a scale | Standard Deviation 5.1 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 28 (n=19, 23) | 26.5 units on a scale | Standard Deviation 11.7 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 1 (n=18, 23) | 19.8 units on a scale | Standard Deviation 5.1 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 1 (n=18, 23) | 17.5 units on a scale | Standard Deviation 3.7 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 28 (n=19, 23) | 75.8 units on a scale | Standard Deviation 12.9 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 1 (n=18, 23) | 14.6 units on a scale | Standard Deviation 4.2 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 1 (n=18, 23) | 18.8 units on a scale | Standard Deviation 8.9 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 28 (n=19, 23) | 62.9 units on a scale | Standard Deviation 18.7 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FACIT-G-Day 1 (n=18, 23) | 68.9 units on a scale | Standard Deviation 11.4 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | TOI-Day 1 (n=18, 23) | 49.4 units on a scale | Standard Deviation 15.3 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 28 (n=19, 23) | 101.3 units on a scale | Standard Deviation 21.9 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 1 (n=19, 23) | 86.1 units on a scale | Standard Deviation 20.4 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Total-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 28 (n=19, 23) | 17.4 units on a scale | Standard Deviation 6.3 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | PWB-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 28 (n=19, 23) | 18.7 units on a scale | Standard Deviation 4.3 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | Fatigue-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | SWB-Day 28 (n=19, 23) | 20.8 units on a scale | Standard Deviation 5.4 |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | EWB-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score | FWB-Day 28 (n=19, 23) | 16.8 units on a scale | Standard Deviation 4.5 |
Comparison: Comparison between arms for Day 28 of treatment- FACIT-F totalp-value: 0.559t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F totalp-value: <0.001t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F totalp-value: 0.192t-test, 2 sided
Comparison: Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F totalp-value: 0.495t-test, 2 sided
Secondary
Hospital Anxiety and Depression Scale (HADS) Score
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.
Time frame: Day 1, Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 1 (n=18, 23) | 13.4 units on a scale | Standard Error 21.4 |
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 1 (n=18, 23) | 7.8 units on a scale | Standard Error 2.7 |
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 28 (n=19, 23) | 6.9 units on a scale | Standard Error 4.6 |
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 28 (n=19, 23) | 10.3 units on a scale | Standard Error 17.8 |
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 56 (n=15) | 7.0 units on a scale | Standard Error 3.4 |
| Armodafinil | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 56 (n=15) | 5.7 units on a scale | Standard Error 2.9 |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 1 (n=18, 23) | 8.3 units on a scale | Standard Error 2.9 |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 28 (n=19, 23) | 6.6 units on a scale | Standard Error 3.6 |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 1 (n=18, 23) | 7.6 units on a scale | Standard Error 3.2 |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Depression-Day 56 (n=15) | NA units on a scale | — |
| Placebo-First | Hospital Anxiety and Depression Scale (HADS) Score | Anxiety-Day 28 (n=19, 23) | 5.5 units on a scale | Standard Error 3.3 |
Comparison: Comparison between arms at Day 28 of treatment- HADS anxietyp-value: 0.945Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms at Day 28 of treatment- HADS depressionp-value: 0.316Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxietyp-value: 0.005t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depressionp-value: 0.005t-test, 2 sided
Comparison: Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxietyp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depressionp-value: 0.315Wilcoxon (Mann-Whitney)
Comparison: Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxietyp-value: 0.933Wilcoxon (Mann-Whitney)
Comparison: Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depressionp-value: 0.378t-test, 2 sided