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

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bright white light
Dim red light
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring fatigue, sleep, quality of life, light, cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioural Medicine Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bright White Light

Dim Red Light

Arm Description

Bright white light exposure every morning for 30 minutes for 28 consecutive days

Dim red light exposure every morning for 30 minutes for 28 consecutive days

Outcomes

Primary Outcome Measures

Change in fatigue symptoms from baseline to post-treatment

Secondary Outcome Measures

Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment
Change in subjective measures of sleep using sleep diaries from baseline to post-treatment
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
Change in Profile of Mood States scores from baseline to post-treatment
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
Change in salivary cortisol from baseline to post-treatment
Change in inflammatory cytokines from baseline to post-treatment
Change in Insomnia Severity Index scores from baseline to post-treatment

Full Information

First Posted
January 22, 2013
Last Updated
April 6, 2016
Sponsor
University of Calgary
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT01780623
Brief Title
An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)
Acronym
LITE
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
fatigue, sleep, quality of life, light, cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright White Light
Arm Type
Experimental
Arm Description
Bright white light exposure every morning for 30 minutes for 28 consecutive days
Arm Title
Dim Red Light
Arm Type
Active Comparator
Arm Description
Dim red light exposure every morning for 30 minutes for 28 consecutive days
Intervention Type
Device
Intervention Name(s)
Bright white light
Other Intervention Name(s)
Light box, LiteBook
Intervention Type
Device
Intervention Name(s)
Dim red light
Other Intervention Name(s)
Light box, LiteBook
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
Time Frame
Baseline, week 5
Title
Change in Profile of Mood States scores from baseline to post-treatment
Time Frame
Baseline, week 5
Title
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
Time Frame
Baseline, week 5
Title
Change in salivary cortisol from baseline to post-treatment
Time Frame
Baseline (for 3 days), week 5 (for 3 days)
Title
Change in inflammatory cytokines from baseline to post-treatment
Time Frame
Baseline, week 5
Title
Change in Insomnia Severity Index scores from baseline to post-treatment
Time Frame
Baseline, week 3, week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tavis S Campbell, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioural Medicine Laboratory
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33070045
Citation
Johnson JA, Subnis U, Carlson LE, Garland SN, Santos-Iglesias P, Piedalue KL, Deleemans JM, Campbell TS. Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Dec;139:110266. doi: 10.1016/j.jpsychores.2020.110266. Epub 2020 Oct 6.
Results Reference
derived

Learn more about this trial

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

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