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Completed

NCT Number: NCT01780623

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

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.

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Key information

Conditions

Cancer Fatigue Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioural Medicine Laboratory

Calgary, Alberta, T2N 1N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright white light

Device

Other names: Light box, LiteBook

Dim red light

Device

Other names: Light box, LiteBook

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment

    Time frame: Baseline, week 5

  4. Change in Profile of Mood States scores from baseline to post-treatment

    Time frame: Baseline, week 5

  5. Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment

    Time frame: Baseline, week 5

  6. Change in salivary cortisol from baseline to post-treatment

    Time frame: Baseline (for 3 days), week 5 (for 3 days)

  7. Change in inflammatory cytokines from baseline to post-treatment

    Time frame: Baseline, week 5

  8. Change in Insomnia Severity Index scores from baseline to post-treatment

    Time frame: Baseline, week 3, week 5

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study 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

Acronym: LITE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2013
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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