E-Newsletter - March 2016

Reducing Cancer-related Fatigue Key Focus of Alliance Study

Cancer-related fatigue is a very common symptom in patients with cancer.  It is one of the most common and most troublesome symptoms for primary brain tumor patients throughout the course of the disease. Radiation therapy is the most common treatment modality for all brain tumor grades, and has been the treatment evaluated in the glioblastoma multiforme (GBM) patient population in relation to fatigue.

In A221101 (A phase III randomized, double-blind placebo controlled study of armodafinil (Nuvigil®) to reduce cancer-related fatigue in patients with glioblastoma multiforme), Alliance researchers will assess how a novel agent works in reducing cancer-related fatigue in patients with high-grade glioma. Armodafinil may help relieve fatigue in patients with GBM. It is a psychostimulant that has shown promise as a cognitive enhancer in normal adults and patient populations, including schizophrenia and attention deficit hyperactivity disorder.

The interventional study aims to determine preliminary efficacy measured by patient reported fatigue of armodafinil in treating moderate fatigue compared to placebo in patients with GBM. It will evaluate the tolerability of two different doses of armodafinil, and assess the effect of armodafinil on cognitive function and the impact of armodafinil on global quality of life and other fatigue endpoints such as usual fatigue and activity interference in this patient population with GBM. In addition, this study will explore the correlation between the Brief Fatigue Inventory (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 eligible to participate in this trial include those with GBM who are clinically stable and have completed radiation therapy more than 21 days and less than 24 months prior to enrollment. Those patients also with a greater than 6 score on the worst fatigue question of the BFI, and those who have 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. (Radiation must be completed, but chemotherapy is allowed.) Patients with a history of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self report will be excluded. In addition, those patients currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc. are ineligible to participate in this study.

Refer to the study protocol (Alliance A221101), which can be found on the CTSU menu (ctsu.org) for complete information on patient eligibility, the trial design and treatment plan. The Alliance Study Co-Chairs are Alyx B. Porter Umphrey, MD, Mayo Clinic, e-mail: Porter.alyx@mayo.edu and and Sadhna Kohli, PhD, MPH, Mayo Clinic, e-mail: Kohli.sadhna@mayo.edu.

1. Osoba D, Brada M, Prados MD, Yung WK. Effect of disease burden on health-related quality of life in patients with malignant gliomas. Neuro-oncology. 2000 Oct; 2(4):221-8.
2. Osoba D, Aaronson NK, Muller M, et al. Effect of neurological dysfunction on health-related quality of life in patients with high-grade glioma. Journal of neuro-oncology. 1997 Sep; 34(3):263-78.



For other articles in the March issue of the Alliance E-News newsletter, see below.