Single Agent Armodafinil for Patient-Reported Fatigue

Condition(s) targeted: Head And Neck Cancer; Fatigue

Intervention: Armodafinil (Drug); Placebo (Other); Questionnaires (Behavioral)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Gary B. Gunn, MD, Principal Investigator, Affiliation: UT MD Anderson Cancer Center

Overall contact:
Gary B. Gunn, MD, Phone: 713-745-3470

The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.

Official title: Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Combined Patient-Reported Fatigue Scores

Detailed description: Armodafinil is designed to stimulate the central nervous system, which may increase wakefulness and reduce fatigue.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If you are found eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take armodafinil. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

You will take the study drug/placebo every day for 4 weeks starting the morning after you have enrolled in this study. You will take the study drug/placebo in the morning with a full glass (8 ounces) of water. You may take the study drug/placebo with or without food. If the dose causes an upset stomach, you should take it with food. If you have trouble swallowing the dose of study drug/placebo, the study staff will tell you of different ways of taking it. You will be given a pamphlet with more information about how to take the study drug/placebo.

Symptom Questionnaires:

Before you start taking the study drug/placebo, the following tests and procedures will be performed:

- You will complete 3 questionnaires about your fatigue, sleepiness, and other symptoms.

These questionnaires should take about 15 minutes to complete total.

- You will complete 3 questionnaires about your quality of life and your ability to work.

These questionnaires should also take about 15 minutes to complete total.

- Your demographic information, such as your marital status, job status, education, and

race will be collected.

Throughout the study, you will complete the 6 symptom questionnaires listed above 2 times every week during the 6 weeks that you are on study. You may complete the questionnaires over the phone with a member of the study staff or during a routinely scheduled visit outside of this study. If you complete the questionnaires over the phone, the study staff will call you at a time that is convenient for you. The study staff will ask you the questions and record your answers on paper or enter them into a computer.

When you complete the questionnaires for the second time each week, you will also be asked if you are taking your study drug/placebo as instructed and you will be asked about any side effects you may be having.

At the end of Week 4, in addition to the 6 symptom questionnaires, you will also complete 4 questionnaires about your sleepiness, quality of life, ability to work, and your thoughts on the study drug/placebo. You will also be asked about any changes in drugs (both prescribed and over the counter) that you may be taking. This should take about 30 minutes.

End-of - Study Questionnaires:

When you are completing the questionnaires for the second time during Week 6, you will also complete 3 additional questionnaires about your quality of life and sleepiness. You will also be asked about any side effects you may be having. This should take about 30 minutes to complete.

Length of Study:

You will be on study for up to 6 weeks. You will take the study drug/placebo for 4 weeks and continue to complete questionnaires for 2 more weeks after that. You will be taken off study if intolerable side effects occur or if the study doctor thinks it is in your best interest.

This is an investigational study. Armodafinil is FDA-approved and commercially available to treat narcolepsy (falling asleep at unexpected times), obstructive sleep apnea, and shift work sleep disorder. It is also FDA-approved and commercially available to treat sleepiness in patients with excessive sleepiness. Its use in this study is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients who were treated with either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer (HNC) with moderate to severe levels of patient reported fatigue during the 6 weeks to 2 years (+/- 1 month) after completing all planned cancer therapy. Patients who rated their fatigue level at 5 or greater on a 0 to 10 scale during routine clinical follow up in the Radiation Oncology Clinic.

2. Male and female patients >= 18 and less than 65 years old.

3. Patients who speak English (due to the novel research and its complexity, we are only accruing English-speaking patients to the protocol).

4. Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.

5. Patients must be willing and able to review and understand informed consent documents and to provide written consent.

6. Women of childbearing potential (women who are not postmenopausal for at least 1 year and are not surgically sterile) must have a negative urine pregnancy test.

7. Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period.

8. Women currently taking birth control pills or planning to start birth control pills must agree to an additional method of birth control (either abstinence or a barrier method) while on the study medication and for 1 additional month after study completion.

Exclusion Criteria:

1. Patients who rated their fatigue level at 4 or less over the past 24 hours based on the fatigue at its worst item of the BFI.

2. Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.

3. Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or PI

4. Patients with Hb <10. 5 g/dL within previous 2 weeks.

5. Patients with untreated or uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >5. 5 mcu/mL or free T4<0. 9 ng/dL within previous 2 weeks.

6. Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.

7. Patients with a Karnofsky performance status <70

8. Patients less than 18 years old or 65 or older

9. Patients who are enrolled and receiving active treatment in other symptom intervention trials or who are in the treatment phase of another clinical trial

10. Patients with pre-existing psychosis or bipolar disorder

11. Patients with pre-existing renal impairment, as evidenced by serum creatinine >1. 5mg/dL on the most recent blood work, done at least within the previous 2 weeks.

12. Patients with pre-existing cirrhosis or hepatic impairment or with abnormal liver function test as evidenced by total bilirubin >25. 7 µmol/L (1. 5 mg/dL) or 2 times the upper limit of normal of alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) on the most recent blood work, done at least within the previous 2 weeks.

13. Patients with pre-existing Tourette's syndrome

14. Patients who have used monoamine oxidase (MAO inhibitors) within the past 14 days

15. Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)

16. Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate

17. Patients on anticoagulants (i. e. warfarin, coumadin, or heparin) or clopidogrel

18. Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions

19. Patients with a history of angina or cardiac ischemia, a recent history of myocardial infarction (within the past 1 year) or left ventricular hypertrophy, or patients with mitral valve prolapse

20. Patients with uncontrolled hypertension or tachycardia, as determined by treating physician

21. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period and for 1 month after stopping the study drug.

22. Female patients who are currently on birth control pills as primary means of contraception, but are not willing to seek an additional effective method of contraception (such as barrier method) during the study period and for 1 month after stopping the study drug.

23. Patients with a history of central nervous system (CNS) stimulant abuse, such as methylphenidate, dextroamphetamine, or modafinil.

24. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS)). If this is the case, we will notify their treating physician for appropriate management or referral.

25. Patients with current or a history of suicidal ideation.

26. Patients currently taking midazolam, cyclosporine, ethinyl estradiol, or triazolam

27. Patients currently taking carbamazepine, phenobarbital, rifampin, aminoglutethimide, nafcillin, nevirapine, phenytoin, azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, or verapamil

28. Patients currently taking omeprazole, diazepam, propanolol, chlomipramine (or other tricyclic antidepressants), citalopram, methsuximide, or sertraline.

Gary B. Gunn, MD, Phone: 713-745-3470

UT MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

UT MD Anderson Website

Starting date: May 2011
Last updated: August 24, 2011