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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Head And Neck Cancer; Fatigue	Drug: Armodafinil; Other: Placebo; Behavioral: Questionnaires	Phase 1; Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
Actual Study Start Date :	May 2011
Estimated Primary Completion Date :	May 2019
Estimated Study Completion Date :	May 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Armodafinil; 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.	Drug: Armodafinil; 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.; Other Name: Nuvigil; Behavioral: Questionnaires; Series of questionnaires completed at different time points before, during, and at study completion.; Other Name: Surveys
Placebo Comparator: Placebo; 1 Placebo by mouth every morning for a 28 day cycle.	Other: Placebo; 1 by mouth every morning for a 28 day cycle.; Other Name: Sugar Pill; Behavioral: Questionnaires; Series of questionnaires completed at different time points before, during, and at study completion.; Other Name: Surveys

Outcome Measures

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Primary Outcome Measures :

1. Combined Patient-Reported Fatigue Scores [ Time Frame: 4-6 weeks ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Gary B. Gunn, MD	M.D. Anderson Cancer Center

More Information

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Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01330446 History of Changes
Other Study ID Numbers:	2010-0557; R01 026582-26 ( Other Grant/Funding Number: National Cancer Institute ); NCI-2011-00881 ( Registry Identifier: NCI CTRP )
First Posted:	April 7, 2011
Last Update Posted:	November 14, 2017
Last Verified:	November 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

Head and Neck Neoplasms; Fatigue; Neoplasms by Site; Neoplasms; Signs and Symptoms; Armodafinil; Modafinil	Wakefulness-Promoting Agents; Central Nervous System Stimulants; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action