Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

Criteria

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.