Alliance A221101

Alliance A221101:  A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

Sponsor: Alliance

Primary Investigator:  Sheetal Acharya, MD

Primary Study Coordinator:  Cherokee Helms-Gleason, LPN

Number of Participants:  330

Length of Study:  8 weeks

What is Armodafinil? Armodafinil, also called Nuvigil® is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.  However, it is not been studied in people with cancer related fatigue.

What type of study is this?  A221101 is a phase 3 clinical trial for people who are experiencing fatigue that is related to cancer.

You may be able to participate in the A221101 trial if you:

Are at least 18 years old

Have confirmed diagnosis of high grade glioblastoma (GBM)

Radiation therapy completed less than 24 months prior enrollment

Why is the A221101 trial being done? The purpose of this study is to see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue and what are the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

What is involved in the study? You will be asked to complete a booklet of six brief questionnaires about fatigue related symptoms and a memory/concentration test. This will be done three times, once before you start taking the study medication, armodafinil or placebo, than again at the end of 4 weeks and 8 weeks you will be randomly assigned (like flipping a coin) to receive either Armodafinil (Nuvigil®) or placebo.

What are the costs of the study? You will not need to pay for tests and procedures which are done just for this research study.  The study agents, armodafinil and placebo, will be supplied at no cost to you or your insurance company. 

You and/or your insurance company will continue to pay for routine health care cost for the management of your cancer.  Some health plans will not pay these costs for people taking part in studies.  Check with your health plan or insurance company to find out what they will pay for.  Taking part in this study may or may not cost your insurance company more than the cost of getting regular cancer treatment.

What are the benefits of being in the study? Taking part in this study may or may not make your health better.  While doctors hope armodafinil will be helpful against cancer related fatigue, there is no proof of this yet. We do know that the information from this study will help doctors learn more about treatment for cancer related fatigue and could help cancer patients in the future.

To inquire about trial eligibility or for additional information, please contact:

UPHS - Marquette Cancer Care:  906-225-3500    toll-free:  1-800-562-9753 ext. 3922

Cherokee Helms-Gleason, LPN:  906-225-7397   toll-free:  1-800-562-9753 ext. 7397

Jodi Nease, RN:  906-225-4687   toll-free: 1-800-562-9753 ext. 4687