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

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780623
• Other study ID #: 10003569
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: April 6, 2016
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Bright white light

• Dim red light

Locations

Country	Name	City	State
Canada	Behavioural Medicine Laboratory	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue symptoms from baseline to post-treatment		Baseline, after each treatment week (each week for 4 weeks), and at week 5	No
Secondary	Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment		Baseline (for 7 days), week 5 (for 7 days)	No
Secondary	Change in subjective measures of sleep using sleep diaries from baseline to post-treatment		Baseline (for 7 days), week 5 (for 7 days)	No
Secondary	Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment		Baseline, week 5	No
Secondary	Change in Profile of Mood States scores from baseline to post-treatment		Baseline, week 5	No
Secondary	Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment		Baseline, week 5	No
Secondary	Change in salivary cortisol from baseline to post-treatment		Baseline (for 3 days), week 5 (for 3 days)	No
Secondary	Change in inflammatory cytokines from baseline to post-treatment		Baseline, week 5	No
Secondary	Change in Insomnia Severity Index scores from baseline to post-treatment		Baseline, week 3, week 5	No