Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01781468|
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Drug: armodafinil 150 mg Other: Placebo Drug: armodafinil 250 mg||Phase 3|
Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.
The secondary objectives of the study are listed below.
- To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
- To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
- To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
- Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the relationship of fatigue and cognitive difficulties.
Patients will receive armodafinil or placebo for a total of 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||328 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||December 15, 2019|
Experimental: Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 150 mg
Placebo Comparator: Arm II
Patients receive placebo orally every day in the morning for 8 weeks.
Experimental: Arm III
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 250 mg
- The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. [ Time Frame: At 8 weeks ]
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks.
Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
- Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks. [ Time Frame: Up to 4 weeks ]A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
- Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8 [ Time Frame: Up to 8 weeks ]The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.
- Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8 [ Time Frame: Up to 8 weeks ]Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0 [ Time Frame: Up to 8 weeks ]The number of participants who experienced at least one grade 3 or higher adverse events deemed at least possibly related to treatment via the CTCAE version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781468
|Study Chair:||Alyx B. Porter Umphrey, MD||Mayo Clinic|