A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 363
- 主要终点
- The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.
研究概览
简要总结
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
- •>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
- •Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
- •Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
- •Provide informed written consent
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- •Stable dose of corticosteroid >= 14 days prior to registration
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
干预措施: armodafinil 150 mg (Drug)
Arm II
Patients receive placebo orally every day in the morning for 8 weeks.
干预措施: Placebo (Other)
Arm III
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
干预措施: armodafinil 250 mg (Drug)
结局指标
主要结局
The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.
时间窗: 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
次要结局
- 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.(Up to 4 weeks)
- 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(Up to 8 weeks)
- Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8(Up to 8 weeks)
- Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8(Up to 8 weeks)