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

NCT01330446 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: 2010-0557R01 026582-26NCI-2011-00881
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Head And Neck Cancer; Fatigue

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Brief Fatigue Inventory-Worst

  The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28 days. The range for BFI-Worst Fatigue AUC is from 0 to 280.

  4-6 weeks

Study Arms (2)

Armodafinil

EXPERIMENTAL

50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.

Drug: Armodafinil; Behavioral: Questionnaires

Placebo

PLACEBO COMPARATOR

1 Placebo by mouth every morning for a 28 day cycle.

Other: Placebo; Behavioral: Questionnaires

Interventions

Armodafinil DRUG

50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.

Also known as: Nuvigil

Armodafinil

Placebo OTHER

1 by mouth every morning for a 28 day cycle.

Also known as: Sugar Pill

Placebo

Questionnaires BEHAVIORAL

Series of questionnaires completed at different time points before, during, and at study completion.

Also known as: Surveys

Armodafinil; Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Male and female patients \>= 18 years old.
• Patients who speak English (due to the novel research and its complexity, we are only accruing English-speaking patients to the protocol).
• Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.
• Patients must be willing and able to review and understand informed consent documents and to provide written consent.
• 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.
• Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period.
• 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.

You may not qualify if:

• 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.
• Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
• Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or PI
• Patients with Hb \<10.5 g/dL within previous 2 weeks.
• Patients with untreated or uncontrolled hypothyroidism, or TSH \> ULN or free T4 \< lower level of normal within previous 2 weeks.
• Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
• Patients with a Karnofsky performance status \<70
• Patients less than 18 years old
• Patients who are enrolled and receiving active treatment in other symptom intervention trials or who are in the treatment phase of another clinical trial
• Patients with pre-existing psychosis or bipolar disorder
• 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.
• 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.
• Patients with pre-existing Tourette's syndrome
• Patients who have used monoamine oxidase (MAO inhibitors) within the past 14 days
• Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Fatigue

Interventions

Modafinil; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Gary B. Gunn
• Organization: University of Texas M D Anderson Cancer Center

gbgunn@mdanderson.org

(713) 563-2562

Study Officials

• Gary B. Gunn, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 7, 2011
• Study Start: May 19, 2011
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-02

Locations

US (2)