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

This study is currently recruiting participants.
Verified January 2013 by University of Calgary
Sponsor:
Collaborator:
Canadian Cancer Society
Information provided by (Responsible Party):
Tavis S. Campbell, University of Calgary
ClinicalTrials.gov Identifier:
NCT01780623
First received: January 22, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Cancer
 Device: Bright white light
Device: Dim red light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in fatigue symptoms from baseline to post-treatment [ Time Frame: Baseline, after each treatment week (each week for 4 weeks), and at week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment [ Time Frame: Baseline (for 7 days), week 6 (for 7 days) ] [ Designated as safety issue: No ]
  • Change in subjective measures of sleep using sleep diaries from baseline to post-treatment [ Time Frame: Baseline (for 7 days), week 6 (for 7 days) ] [ Designated as safety issue: No ]
  • Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change in Profile of Mood States scores from baseline to post-treatment [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change in salivary cortisol from baseline to post-treatment [ Time Frame: Baseline (for 3 days), week 6 (for 3 days) ] [ Designated as safety issue: No ]
  • Change in inflammatory cytokines from baseline to post-treatment [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
  • Change in Insomnia Severity Index scores from baseline to post-treatment [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780623

Contacts
Contact: Jillian A Johnson, BSc 403-210-8606 lite@ucalgary.ca
Contact: Kristin Horsely 403-210-8606 behmed@ucalgary.ca

Locations
Canada, Alberta
Behavioural Medicine Laboratory Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Tavis S Campbell, PhD     403-210-8606     t.s.campbell@ucalgary.ca    
Contact: Jillian A Johnson, BSc     403-210-8606     lite@ucalgary.ca    
Principal Investigator: Tavis S Campbell, PhD            
Sponsors and Collaborators
University of Calgary
Canadian Cancer Society
Investigators
Principal Investigator: Tavis S Campbell, PhD University of Calgary
  More Information

No publications provided

Responsible Party: Tavis S. Campbell, Dr. Tavis S. Campbell, University of Calgary
ClinicalTrials.gov Identifier: NCT01780623     History of Changes
Other Study ID Numbers: 10003569
Study First Received: January 22, 2013
Last Updated: January 28, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
fatigue
sleep
quality of life
light
cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013