Single Agent Armodafinil for Patient-Reported Fatigue

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01330446
First received: April 5, 2011
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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
Fatigue
Drug: Armodafinil
Other: Placebo
Behavioral: Questionnaires
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330446

Contacts
Contact: Gary B. Gunn, MD 713-745-3470

Locations
United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gary B. Gunn, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01330446     History of Changes
Other Study ID Numbers: 2010-0557, R01 026582-26, NCI-2011-00881
Study First Received: April 5, 2011
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

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:
Fatigue
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Signs and Symptoms
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 22, 2014