CLINICAL TRIAL

Armodafinil for Fatigue

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.

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About the trial for Fatigue

Eligible Conditions
Fatigue · Head and Neck Neoplasms · Head and Neck Carcinoma

Treatment Groups

This trial involves 2 different treatments. Armodafinil is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Armodafinil
DRUG
Questionnaires
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER
Questionnaires
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Armodafinil
FDA approved
Questionnaires
2013
Completed Phase 2
~2510

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Some patients who were treated for head and neck cancer with radiation or chemoradiation therapy reported feeling fatigued six or more weeks after completing all planned cancer therapy show original
Because of the novel research and its complexity, we are only enrolling English-speaking patients in the study. show original
People must be willing and able to review and understand informed consent documents and agree to them by providing written consent. show original
All sexually active participants in the study must agree to use contraception or abstain from sex during the study period. show original
Patients must not take any herbal supplements while on protocol. show original
Women who are able to have children must have a negative urine pregnancy test. show original
Women currently taking birth control pills or planning to start birth control pills must agree to use a barrier method while on the study medication and for 1 additional month after study completion. show original
All male and female patients who are at least 18 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4-6 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 4-6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4-6 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Armodafinil will improve 1 primary outcome in patients with Fatigue. Measurement will happen over the course of 4-6 weeks.

Combined Patient-Reported Fatigue Scores
4-6 WEEKS
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).
4-6 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for fatigue?

There may be an overlap with treatments for depression and fatigue in chronic fatigue syndrome. There can also be a strong correlation between fatigue and depression (CFS) but evidence as to whether this correlation is causal or simply correlational or both is limited.

Anonymous Patient Answer

What are the signs of fatigue?

The major signs and symptoms of fatigue are related to the underlying cause of fatigue, not the medical term for “fatigue”. However, the medical term “fatigue” is still commonly used. The following are some of the major signs/symptoms that are associated with fatigue.\n- Persistent fatigue can be a major symptom of depression or a side effect of certain medications such as selective serotonin re-uptake inhibitors (SSRIs) and monoamine oxidase inhibitors (MAOIs).\n- Cognitive impairment, which could include difficulty with memory, attention, planning, or reasoning, may persist in depression. Furthermore, depression is often associated with cognitive impairment.

Anonymous Patient Answer

Can fatigue be cured?

In terms of reduction from baseline fatigue scores, the best reduction is achieved using nonopioid medications, and this effect is maintained over time. In patients with low initial baseline fatigue scores, fatigue reduction can also be achieved with opioid medications, but this reduction is not maintained in the long term.

Anonymous Patient Answer

What is fatigue?

A diagnosis of CFS seems to be associated with both high levels of fatigue (vitamin B12 serum values < 190 pg/ml) and high levels of fatigue (self-reported by the patient) during the past year. Data from a recent study is limited by a small number of subjects, but these results suggest that levels of vitamin B12 and self-reported levels of fatigue may be complementary and helpful tools, in the diagnosis of CFS in addition to other criteria, for determining both the severity and the phenotype of the illness.

Anonymous Patient Answer

What causes fatigue?

Although the pathophysiology of fatigue continues to be debated, a vast majority of studies have reported a reduced aerobic capacity or a high metabolic and muscular sympathetic nervous system activity in fatigued subjects. The reduction of aerobic capacity may exacerbate the exhaustion of a workload in subjects with fatigue.

Anonymous Patient Answer

How many people get fatigue a year in the United States?

About 10% of adults in the United States say they 'often feel tired.' This is more common in adult males, with the exception of college graduates. The most common reasons for fatigue included insufficient sleep and physical activity. Subjective fatigue impacts a higher percentage of working adults than objective fatigue or depression symptoms, and is associated with poorer daily functioning.

Anonymous Patient Answer

What are the chances of developing fatigue?

The data presented here have been reported on in hundreds of published [research articles] which indicate that the data presented are valid and generalizable, being similar to studies of other groups (i.e. age, gender, etc.). However, it is important to note the differences inherent in any sample, since some groups are more likely to experience fatigue than others. It is also possible that some groups could, in fact, produce more fatigue from the tests (i.e. those who have worked for longer hours in the past months, or have a higher body temperature).

Anonymous Patient Answer

Who should consider clinical trials for fatigue?

Most patients were not interested in enrolling in clinical trials of treatments to relieve fatigue. There was little interest by patients who were older than 75 years. More than 90% of patients did not think it was necessary to enroll in a clinical trial for fatigue if their disease was mild but only 20% of respondents said they were willing to enroll in a trial with a moderate level of fatigue.

Anonymous Patient Answer

Does armodafinil improve quality of life for those with fatigue?

Subjects receiving placebo and subjects on the armodafinil dose experienced a mean change on the SF-36 physical function domain of 7.3 (6.0-7.9) and 6.6 (4.7-7.8) points and a mean change on the QoL interference with activities domain of 7 (5.5-9) and 6.5 (4.5-7.3) points, respectively, with armodafinil subjects. In addition, in the armodafinil group, 2 of 30 patients reported an improvement in QoL.

Anonymous Patient Answer

What are the common side effects of armodafinil?

Armodafinil has a well balanced tolerability profile, which is particularly supportive of its potential for use in the elderly. Results from a recent clinical trial imply that armodafinil could be a desirable drug for sleep-related disorders in the elderly. This trial was registered at www.anzctr.org.au as ACTRN12606300022536.

Anonymous Patient Answer

What is the primary cause of fatigue?

Primary-cause fatigue was found to be the most common symptom in patients with CFS. This suggests that in addition to a primary neurophysiological dysfunction, there may be a predisposing psychiatric component with regard to primary-cause fatigue.

Anonymous Patient Answer
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