An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study) (LITE)
April 6, 2016 updated by: Tavis S. Campbell, University of Calgary
A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 1N4
- Behavioural Medicine Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Bright White Light
Bright white light exposure every morning for 30 minutes for 28 consecutive days
|
Other Names:
|
|
ACTIVE_COMPARATOR: Dim Red Light
Dim red light exposure every morning for 30 minutes for 28 consecutive days
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in fatigue symptoms from baseline to post-treatment
Time Frame: Baseline, after each treatment week (each week for 4 weeks), and at week 5
|
Baseline, after each treatment week (each week for 4 weeks), and at week 5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment
Time Frame: Baseline (for 7 days), week 5 (for 7 days)
|
Baseline (for 7 days), week 5 (for 7 days)
|
|
Change in subjective measures of sleep using sleep diaries from baseline to post-treatment
Time Frame: Baseline (for 7 days), week 5 (for 7 days)
|
Baseline (for 7 days), week 5 (for 7 days)
|
|
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
Time Frame: Baseline, week 5
|
Baseline, week 5
|
|
Change in Profile of Mood States scores from baseline to post-treatment
Time Frame: Baseline, week 5
|
Baseline, week 5
|
|
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
Time Frame: Baseline, week 5
|
Baseline, week 5
|
|
Change in salivary cortisol from baseline to post-treatment
Time Frame: Baseline (for 3 days), week 5 (for 3 days)
|
Baseline (for 3 days), week 5 (for 3 days)
|
|
Change in inflammatory cytokines from baseline to post-treatment
Time Frame: Baseline, week 5
|
Baseline, week 5
|
|
Change in Insomnia Severity Index scores from baseline to post-treatment
Time Frame: Baseline, week 3, week 5
|
Baseline, week 3, week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
April 1, 2015
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (ESTIMATE)
January 31, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.