Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169753
Recruitment Status : Terminated (Slow Enrollment)
First Posted : July 26, 2010
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Placebo Drug: Armodafinil Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)
Study Start Date : May 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients randomized to nonintervention will take a placebo every morning for 2 weeks.
Drug: Placebo
Oral tablet every morning for 2 weeks

Experimental: Armodafinil
Three 50 mg tablets orally every morning for 2 weeks.
Drug: Armodafinil
Three 50 mg tablets orally every morning for 2 weeks.
Other Name: Nuvigil

Primary Outcome Measures :
  1. Number of Participants With "Fatigue Worst" BFI Score [ Time Frame: After each 2 week treatment ]
    Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.

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

Inclusion Criteria:

  1. Patients with CML on imatinib, dasatinib or nilotinib (or any other FDA approved tyrosine kinase inhibitor (TKI) for CML)
  2. Must be >/= 18 years of age
  3. Must have "fatigue worst" on The Brief Fatigue Inventory > or = 4
  4. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (refer to protocol for acceptable methods of contraception). Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control. Both men and women must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
  5. Informed consent must be signed
  6. Patient should have at least a complete cytogenetic response (CCyR) sustained for the last 6 months
  7. Patient should be receiving stable dose of TKI for at least 3 months (i.e. no increase or decrease in dose during this period) and should not have treatment interruptions for more than 7 consecutive days during this time period unless this was exclusively because of fatigue.
  8. Females must have a negative serum pregnancy test within 48 hours prior to beginning treatment on this trial
  9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at baseline

Exclusion Criteria:

  1. History of hypersensitivity or allergy to armodafinil, modafinil or any component of the formulation of armodafinil.
  2. History of or current seizures, glaucoma, major psychiatric diagnosis (psychiatric illness that required hospitalization), narcolepsy or Tourette's syndrome
  3. History of severe headaches or increased agitation within the last 90 days prior to enrollment
  4. History of clinically significant uncontrolled pulmonary or cardiac disease (uncontrolled is defined as patients requiring changes in dose and/or start of a new course of treatment in the last 30 days). This may include disease states as congestive heart failure, cardiac arrhythmias, coronary artery disease, chronic obstructive pulmonary disease and asthma)
  5. Uncontrolled hypertension. Patients that have not been on a stable treatment dose for the past month or have a systolic blood pressure consistently (consistently is defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg
  6. History of fibromyalgia
  7. History or current abuse of alcohol or drugs
  8. Moderate to severe depression as measured on the Depression Anxiety Stress Scale (DASS-21)
  9. If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days
  10. Currently taking psychostimulants (including appetite suppressants), L-Monoamine oxidases (MAO) inhibitors, anticoagulant therapy, anticonvulsant therapy or current consumption of alcohol within 8 hours of enrollment.
  11. Current use of corticosteroids, stimulants, or other medications used to improve fatigue symptoms. Topical corticosteroids or occasional, intermittent doses of systemic steroids (e.g., for pre-medications, etc) are allowed
  12. On clinical trials listing Armodafinil as a prohibited medication within the last 30 days of enrollment
  13. Use of the following herbals or supplements for fatigue relief within the last 30 days (including dehydroepiandrosterone (DHEA), SAMe, ginkgo, ginseng, green, black or Chinese tea, ephedra (aka-ma-huang), popotillo and Mormon tea
  14. Any coexisting medical condition or taking any concomitant medication that is likely to interfere with the safe administration of armodafinil
  15. Hemoglobin < 8 gm/dl at time of enrollment
  16. Albumin value 50% lower than the lower limit of normal
  17. Evidence of hepatic impairment (total bilirubin > or = 2.5 times Upper limits of normal (ULN), serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)
  18. Evidence of renal impairment (serum creatinine > 2.5 times ULN)
  19. If taking opioids, anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days
  20. Patients who were ever in blast phase of CML
  21. Female patients who are pregnant or breastfeeding
  22. History of mitral valve prolapse documented by cardiac study.
  23. Patients with history or current suicidal ideation
  24. Currently taking strong cytochrome P450 3A4 (CYP3A4) inducers (including but not limited to phenobarbital, phenytoin, rifampin,and troglitazone); strong CYP3A4 inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin and grapefruit juice)
  25. Patients who have been transplanted and are on immunosuppressive therapies that may interfere with TKI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169753

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Carmen Escalante, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01169753     History of Changes
Other Study ID Numbers: 2009-0638
NCI-2011-00895 ( Registry Identifier: NCI CTRP )
First Posted: July 26, 2010    Key Record Dates
Results First Posted: December 8, 2015
Last Update Posted: December 8, 2015
Last Verified: November 2015

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Signs and Symptoms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
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