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

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ClinicalTrials.gov Identifier: NCT01780623
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Device: Bright white light Device: Dim red light

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : January 2013
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bright White Light
Bright white light exposure every morning for 30 minutes for 28 consecutive days
Device: Bright white light
Other Names:
  • Light box
  • LiteBook
Active Comparator: Dim Red Light
Dim red light exposure every morning for 30 minutes for 28 consecutive days
Device: Dim red light
Other Names:
  • Light box
  • LiteBook


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment [ Time Frame: Baseline, week 5 ]
  4. Change in Profile of Mood States scores from baseline to post-treatment [ Time Frame: Baseline, week 5 ]
  5. Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment [ Time Frame: Baseline, week 5 ]
  6. Change in salivary cortisol from baseline to post-treatment [ Time Frame: Baseline (for 3 days), week 5 (for 3 days) ]
  7. Change in inflammatory cytokines from baseline to post-treatment [ Time Frame: Baseline, week 5 ]
  8. Change in Insomnia Severity Index scores from baseline to post-treatment [ Time Frame: Baseline, week 3, week 5 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780623


Locations
Canada, Alberta
Behavioural Medicine Laboratory
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Tavis S Campbell, PhD University of Calgary
More Information

Responsible Party: Tavis S. Campbell, Dr. Tavis S. Campbell, University of Calgary
ClinicalTrials.gov Identifier: NCT01780623     History of Changes
Other Study ID Numbers: 10003569
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Tavis S. Campbell, University of Calgary:
fatigue
sleep
quality of life
light
cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms