Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Ne… (NCT01330446) | Clinical Trial Compass
CompletedPhase 1/2
Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer
United States26 participantsStarted 2011-05-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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