Clinical trial NCT01780623: An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)
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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: fatigue
sleep
quality of life
light
cancer
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2013-01-31
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in fatigue symptoms from baseline to post-treatment
timeFrame: Baseline, after each treatment week (each week for 4 weeks), and at week 5
Secondary outcomes:
measure: Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment
timeFrame: Baseline (for 7 days), week 5 (for 7 days)
measure: Change in subjective measures of sleep using sleep diaries from baseline to post-treatment
timeFrame: Baseline (for 7 days), week 5 (for 7 days)
measure: Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
timeFrame: Baseline, week 5
measure: Change in Profile of Mood States scores from baseline to post-treatment
timeFrame: Baseline, week 5
measure: Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
timeFrame: Baseline, week 5
measure: Change in salivary cortisol from baseline to post-treatment
timeFrame: Baseline (for 3 days), week 5 (for 3 days)
measure: Change in inflammatory cytokines from baseline to post-treatment
timeFrame: Baseline, week 5
measure: Change in Insomnia Severity Index scores from baseline to post-treatment
timeFrame: Baseline, week 3, week 5
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Behavioural Medicine Laboratory
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tavis S Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.