Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01781468|
Recruitment Status : Recruiting
First Posted : February 1, 2013
Last Update Posted : May 8, 2018
|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)|
|Estimated Enrollment :||330 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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2020|
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
- Response rate in terms of a clinically meaningful improvement in patient-reported fatigue 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). [ Time Frame: Up to 8 weeks ]
- Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ]
- Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ]
- Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ]
- Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781468
|Contact: Alyx B. Porter Umphrey, MD||(507) 266-5230|
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|Study Chair:||Alyx B. Porter Umphrey, MD||Mayo Clinic|