An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)

Study Overview
=================
Brief Summary
-----------------
Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.

Official Title
-----------------
A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Bright white light
* Device: Dim red light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Non metastatic cancer At least 3 months post chemotherapy/radiation treatment (hormone treatment ok) Meets criteria for cancer-related fatigue Exclusion Criteria: Under 18 years of age Presence of a sleep disorder other than insomnia or hypersomnia Shift work Presence of an Axis-I psychiatric condition Presence of a medical condition that may impact levels of fatigue Presence of conditions contraindicated to the use of light therapy or photosensitizing medications Randomization refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright White Light<br>Bright white light exposure every morning for 30 minutes for 28 consecutive days | Device: Bright white light<br> <br> * Other names: LiteBook;|
| Active Comparator: Dim Red Light<br>Dim red light exposure every morning for 30 minutes for 28 consecutive days | Device: Dim red light<br> <br> * Other names: LiteBook;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue symptoms from baseline to post-treatment |  | Baseline, after each treatment week (each week for 4 weeks), and at week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment |  | Baseline (for 7 days), week 5 (for 7 days) | 
| Change in subjective measures of sleep using sleep diaries from baseline to post-treatment |  | Baseline (for 7 days), week 5 (for 7 days) | 
| Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment |  | Baseline, week 5 | 
| Change in Profile of Mood States scores from baseline to post-treatment |  | Baseline, week 5 | 
| Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment |  | Baseline, week 5 | 
| Change in salivary cortisol from baseline to post-treatment |  | Baseline (for 3 days), week 5 (for 3 days) | 
| Change in inflammatory cytokines from baseline to post-treatment |  | Baseline, week 5 | 
| Change in Insomnia Severity Index scores from baseline to post-treatment |  | Baseline, week 3, week 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, sleep, quality of life, light, cancer