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

  • Canada
    • 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
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

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

University of Calgary

Collaborators

Canadian Cancer Society (CCS)

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.

General Publications

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10003569

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.

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