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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Device: Dim red light; Device: Bright white light

• Registration Number: NCT01780623
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-31
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dim Red Light	Dim red light	Dim red light exposure every morning for 30 minutes for 28 consecutive days
Bright White Light	Bright white light	Bright white light exposure every morning for 30 minutes for 28 consecutive days

Primary Outcome Measures

Name	Time	Method
Change in fatigue symptoms from baseline to post-treatment	Baseline, after each treatment week (each week for 4 weeks), and at week 5

Secondary Outcome Measures

Name	Time	Method
Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment	Baseline (for 7 days), week 5 (for 7 days)
Change in subjective measures of sleep using sleep diaries from baseline to post-treatment	Baseline (for 7 days), week 5 (for 7 days)
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment	Baseline, week 5
Change in Profile of Mood States scores from baseline to post-treatment	Baseline, week 5
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment	Baseline, week 5
Change in salivary cortisol from baseline to post-treatment	Baseline (for 3 days), week 5 (for 3 days)
Change in inflammatory cytokines from baseline to post-treatment	Baseline, week 5
Change in Insomnia Severity Index scores from baseline to post-treatment	Baseline, week 3, week 5

Trial Locations

Locations (1)

Behavioural Medicine Laboratory; 🇨🇦 Calgary, Alberta, Canada