Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Fatigue

Treatments: Drug: armodafinil 150 mg; Other: Placebo; Drug: armodafinil 250 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01781468

N10C3

UG1CA189823 (U.S. NIH Grant/Contract)

U10CA037404 (U.S. NIH Grant/Contract)

U10CA037447 (U.S. NIH Grant/Contract)

NCI-2012-02020 (Registry Identifier)

A221101

Details and patient eligibility

About

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.

Full description

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.

1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
4. 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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 3 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.

Treatment:

Drug: armodafinil 150 mg

Arm II

Placebo Comparator group

Description:

Patients receive placebo orally every day in the morning for 8 weeks.

Treatment:

Other: Placebo

Arm III

Experimental group

Description:

Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.

Treatment:

Drug: armodafinil 250 mg