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Single Agent Armodafinil for Patient-Reported Fatigue

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: April 5, 2011
Last updated: November 3, 2016
Last verified: November 2016
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 Intervention Phase
Head And Neck Cancer
Drug: Armodafinil
Other: Placebo
Behavioral: Questionnaires
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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).

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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

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 or 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01330446

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center 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 )
Study First Received: April 5, 2011
Last Updated: November 3, 2016

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Patient-Reported Fatigue
Fatigue-Symptom Intervention
Postoperative Radiation Therapy
Postoperative Chemoradiation Therapy
Sugar Pill

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Signs and Symptoms
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 processed this record on May 25, 2017