| Eligibility |
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 any follow-up
clinic visits at MD Anderson.
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.
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