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

NCT01169753 | Terminated Results DMC

• 2 other identifiers: 2009-0638NCI-2011-00895
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid Leukemia; CML; Nuvigil; Armodafinil; Fatigue

Outcome Measures

Primary Outcomes (1)

• Number of Participants With "Fatigue Worst" BFI Score

  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.

  After each 2 week treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients randomized to nonintervention will take a placebo every morning for 2 weeks.

Drug: Placebo

Armodafinil

EXPERIMENTAL

Three 50 mg tablets orally every morning for 2 weeks.

Drug: Armodafinil

Interventions

Placebo DRUG

Oral tablet every morning for 2 weeks

Placebo

Armodafinil DRUG

Three 50 mg tablets orally every morning for 2 weeks.

Also known as: Nuvigil

Armodafinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CML on imatinib, dasatinib or nilotinib (or any other FDA approved tyrosine kinase inhibitor (TKI) for CML)
• Must be \>/= 18 years of age
• Must have "fatigue worst" on The Brief Fatigue Inventory \> or = 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.
• Informed consent must be signed
• Patient should have at least a complete cytogenetic response (CCyR) sustained for the last 6 months
• 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.
• Females must have a negative serum pregnancy test within 48 hours prior to beginning treatment on this trial
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at baseline

You may not qualify if:

• History of hypersensitivity or allergy to armodafinil, modafinil or any component of the formulation of armodafinil.
• History of or current seizures, glaucoma, major psychiatric diagnosis (psychiatric illness that required hospitalization), narcolepsy or Tourette's syndrome
• History of severe headaches or increased agitation within the last 90 days prior to enrollment
• 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)
• 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
• History of fibromyalgia
• History or current abuse of alcohol or drugs
• Moderate to severe depression as measured on the Depression Anxiety Stress Scale (DASS-21)
• If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days
• 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.
• 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
• On clinical trials listing Armodafinil as a prohibited medication within the last 30 days of enrollment
• 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
• Any coexisting medical condition or taking any concomitant medication that is likely to interfere with the safe administration of armodafinil
• Hemoglobin \< 8 gm/dl at time of enrollment

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cephalon: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Carmen Escalante, MD / Chair, General Internal Medicine
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Carmen Escalante, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 26, 2010
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 8, 2015
• Results First Posted: December 8, 2015

Record last verified: 2015-11

Locations

US (1)