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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head And Neck Cancer, Fatigue

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Trial Information

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


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 6 questionnaires about your fatigue, sleepiness, and other symptoms as
well as your quality of life and your ability to work. These questionnaires should take
about 20 minutes to complete total.

Throughout the study, you will complete 2 of the symptom questionnaires listed above 2 times
every week while you are on study, including during the Open-label Extension Phase
(described below). You may complete the questionnaires over the phone using the Interactive
Voice Response (IVR) system or with a member of the study staff. Another option is to
complete the questionnaires during a routinely scheduled visit outside of this study. If you
complete the questionnaires over the phone, the study staff or the IVR system will call you
at a time that is convenient for you. If the questionnaires are completed through the IVR
system, the study staff will give you the information you need to report your symptoms by
using the system. If the questionnaires are completed with the study staff, she/he 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. If the questionnaires were completed through the IVR system, the
study staff will contact you and ask you if you are taking your study drug/placebo as
instructed and about any side effects you may be having.

At the end of Week 4, you will complete the same set of 6 questionnaires that you completed
at the beginning of the study. You will also complete a questionnaire about 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.

Open-label Extension:

At the end of Week 4, if you were in Group 1 and you did not have any intolerable side
effects, you will be able to continue taking armodafinil for an additional 4 weeks. If you
were in Group 2 and you did not have any intolerable side effects, you will be given the
option to begin receiving armodafinil for 4 weeks.

No matter what you choose, you will not be told whether you were taking the study drug or
the placebo during the first 4 weeks of the study.

If you are in the open-label extension phase, at the end of Week 8, you will complete the
same set of 6 questionnaires that you completed at the beginning of the study. You will also
complete a questionnaire about your thoughts on the study drug/placebo. This should take
about 30 minutes.

Length of Treatment:

You will receive the study drug/placebo for either 4 or 8 weeks. You will be taken off
study if intolerable side effects occur or if the study doctor thinks it is in your best
interest.

Follow-Up:

After your last dose of the study drug/placebo, you will continue to complete 2 symptom
questionnaires for another 4 weeks. The last time you complete the 2 questionnaires, you
will complete an additional 3 questionnaires that you completed at the beginning of the
study.

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. Up to 25 will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients who were treated with either definitive or postoperative radiation or
chemoradiation therapy for HNC with moderate to severe levels of patient reported
fatigue, at 6 or more weeks 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 at MD Anderson, or during routine clinical
follow up at LBJ Hospital.

2. Male and female patients >= 18 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 TSH > ULN or free T4 <
lower level of normal 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

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 > ULN
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 > 1.5 x ULN 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 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Combined Patient-Reported Fatigue Scores

Outcome Description:

Combined 4-week area under the curve (AUC) for the patient-reported "fatigue at its worst" item from the Brief Fatigue Inventory - BFI using a 0 (no fatigue) to 10 scale (worst fatigue).

Outcome Time Frame:

4-6 weeks

Safety Issue:

No

Principal Investigator

Gary B. Gunn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0557

NCT ID:

NCT01330446

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Fatigue
  • Head and Neck Cancer
  • HNC
  • Fatigue
  • Patient-Reported Fatigue
  • Fatigue-Symptom Intervention
  • Postoperative Radiation Therapy
  • Postoperative Chemoradiation Therapy
  • Armodafinil
  • Nuvigil
  • Placebo
  • Sugar Pill
  • Questionnaires
  • Surveys
  • Fatigue
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030