CLINICAL TRIAL

Intervention systematic light exposure for Fatigue

Recruiting · 18+ · Male · Chicago, IL

This study is evaluating whether light exposure may help prevent fatigue in prostate cancer patients undergoing radiation therapy.

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About the trial for Fatigue

Eligible Conditions
Prostatic Neoplasms · Depression · Prostate Cancer · Fatigue · Sleep · Quality of Life (QOL)

Treatment Groups

This trial involves 2 different treatments. Intervention Systematic Light Exposure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Intervention systematic light exposure
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Comparison systematic light exposure
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention systematic light exposure
2016
N/A
~50

Eligibility

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
This is a statement asking if someone is 18 years of age or older. 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: 2 months after the intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 months after the intervention.
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 Intervention systematic light exposure will improve 2 primary outcomes, 8 secondary outcomes, and 6 other outcomes in patients with Fatigue. Measurement will happen over the course of Baseline.

Chronotype
BASELINE
Morningness-eveningness questionnaire. From the item itself: "Scores can range from 4-25. Scores of 7 and below indicate "evening types." Scores of 22 and above indicate "morning types." Scores between 8-21 indicate "intermediate types."
Usage of light box
THROUGHOUT INTERVENTION PERIOD (8 WEEKS)
integrated meter measurement and Litebook log. Length of time light box has been used.
Credibility/Expectancy
BASELINE
Credibility/Expectancy questionnaire. There are two scales used during the questionnaire - (1-9, and 0-100%). A composite score can be calculated for each factor (expectancy and credibility).
Fatigue FACIT-Fatigue scores
BASELINE
FACIT-Fatigue scores
Physical health
BASELINE
Goldin Leisure Time Exercise Questionnaire. From the measure itself: " For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) The second question is used to calculate the frequency of weekly leisure-time activities pursued "long enough to work up a sweat" (see questionnaire)."
BMI
BASELINE
BMI table
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Who is running the study

Principal Investigator
L. M. W.
Prof. Lisa M. Wu, Assistant Professor
Northwestern University

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 is fatigue?

Fatigue is a complex complaint and it remains a challenge to explore, as the precise cause of fatigue remains unclear. The most widely accepted proposed cause of fatigue in MS is the notion of the 'neurogenic hypothesis,' which considers that increased intracranial pressure (ICP) in MS causes a release of dopamine, which in many ways can be analogous to the dopamine released from the brain stem during sleep, leading to a feeling of fatigue. Recent evidence have shown that fatigue is not in fact associated with a higher ICP, nor with increased dopamine levels.

Anonymous Patient Answer

What causes fatigue?

Fatigue is a complicated condition, involving many different factors, including physical, psychological, medical, and environmental. The common symptom is the inability to concentrate, or to complete tasks, normally achievable in the days before the onset of fatigue. The brain's need for oxygen, glucose, and ATP is often hampered during sleep in this disorder.

Anonymous Patient Answer

Can fatigue be cured?

Patients whose symptoms of fatigue were alleviated, the severity of fatigue diminished, and their fatigue perceived as worse by patients who had fatigue that was not cured are candidates to receive fatigue-resolving treatments.

Anonymous Patient Answer

What are the signs of fatigue?

Symptoms of fatigue include: lethargy or feeling tired most of the time, being unable to do one's usual tasks for a long time, feeling tired in one's muscles, and a general feeling of weakness. Symptoms of fatigue last for more than two weeks and signify a prolonged state and can be severe, such as the case of patients in cancer or neurological conditions. In the present study, the correlations and relationships among depressive symptoms with fatigue symptoms were weak. The effect of depressive disorders on fatigue symptoms warrants further studies.

Anonymous Patient Answer

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

More than 1 billion women and men are affected by fatigue in the United States. These patients experience physical and mental health conditions that, in part, arise from reduced overall productivity, with reduced efficiency and productivity losses of US$15.5 billion per year.

Anonymous Patient Answer

What are common treatments for fatigue?

Physical factors like sleep deprivation and fatigue are not an uncommon problem in clinical practice. Patients should be encouraged to sleep well and get regular exercise. Physical activities such as yoga and yoga therapy can help many patients achieve a feeling of "mental energy". This is in agreement with the fact that yoga is an easy way to gain a feeling of "physical energy".

Anonymous Patient Answer

Have there been other clinical trials involving intervention systematic light exposure?

[Systematic light exposure was not effective in changing fatigue outcomes among women with cancer in our study. It is possible that low methodological quality, small sample size, and low adherence with the treatment method may be the reasons explaining our results.

Anonymous Patient Answer

What is the primary cause of fatigue?

In a recent study, findings demonstrates three important aspects: 1. The existence of primary fatigue may be clinically significant; 2. The possibility that the symptom may relate to multiple organic and psychological causes might offer a new target for evaluating primary and/or "secondary" fatigue; and 3. A more effective method to identify a patient's etiology may be required to improve the efficiency and effectiveness of patient management.

Anonymous Patient Answer

How does intervention systematic light exposure work?

The magnitude of intervention effect on objective physical fatigue-burden, activity-intensity, and fatigue-burden may be limited by a small effect on self-reported sleep quality at the intervention site.

Anonymous Patient Answer

What does intervention systematic light exposure usually treat?

This small sample study highlights the need for improved standardisation in defining and administering intervention light exposure in studies. Although the intervention was beneficial, our data does not show the clinical impact of light therapy as a treatment. Further prospective studies with a similar intervention as used in this study are required.

Anonymous Patient Answer

What is the average age someone gets fatigue?

In people over 65, FQS and WQS are often used as scales for estimating levels of fatigue in older adults. However, for younger children, the concept of mild fatigue is not applicable. [See comments/concern section.

Anonymous Patient Answer

What is the latest research for fatigue?

Current research in fatigue is focused mainly on fatigue pathophysiology, as reported in numerous scientific articles and scientific abstracts. However, there are many unresolved questions in this area which could help to develop more effective interventions.

Anonymous Patient Answer
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