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Completed

NCT Number: NCT02658708

Bright Light on Fatigue in Women Being Treated for Breast Cancer

This proposed study will examine feasibility and implement therapeutic bright light that is tailored to the individual's circadian typology to estimate its therapeutic effects on sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.

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Key information

Conditions

Breast Neoplasms Breast Cancer Breast Diseases Cancer of Breast Cancer of the Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 21 years of age or older
  • Newly diagnosed with stage I-III breast cancer
  • Scheduled to receive 21-day cycles of intravenous chemotherapy
  • Experiencing disrupted sleep (determined by Pittsburgh Sleep Quality Index)
  • Morning or evening types (determined by Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
  • Sighted
  • Mentally competent to consent
  • Able to under English

Exclusion criteria

  • Concurrent malignancy
  • Undergoing other cancer treatments
  • Engage in shift work or travel across more than 3 time zones within 2 weeks prior to study
  • Known history of seasonal affective disorder or substance abuse
  • Current diagnosis of major Axis I psychiatric disorders, neurological impairments, or muscular dystrophies
  • Regularly use steroid or other immunosuppressive medications
  • Take prescribed sedative hypnotics or sleep medications because these conditions may affect fatigue and/or sleep/wake patterns.
  • Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g. migraine), or take photosensitizing medications (e.g. some porphyrin drugs, antipsychotics, antiarrhythmic agents)

Treatment and study plan

Bright blue-green light using light visor cap

Other

Dim red light using light visor cap

Other

European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire

Other

-Consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life

Other names: EORCT QLQ C-30

Epworth Sleepiness Scale

Other

-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period

Other names: ESS

Pittsburgh Sleep Quality Index

Other

-Contains 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance

Other names: PSQI

Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance

Other

-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances

Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue

Other

-Consists of 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue.

Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)

Diagnostic Test

-The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.

Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)

Diagnostic Test

-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed

Other names: PSG

Horne-Ostberg Morningness-Eveningness Questionnaire

Other

Other names: MEQ

Daily Fatigue and Sleep Log

Other
  • Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
  • Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)

Primary outcomes

  1. Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording

    Time frame: Through completion of study (approximately 50 days)

    -Feasibility of the procedures will be assessed by descriptive analysis

  2. Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue

    Time frame: Through completion of study (approximately 50 days)

  3. Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log

    Time frame: Through of completion of study (approximately 43 days)

  4. Effect of bright light on sleep patterns as measured by PSG

    Time frame: Through completion of study (approximately 50 days)

  5. Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance

    Time frame: Through of completion of study (approximately 43 days)

  6. Effect of bight light on sleep patterns as measured by PSQI

    Time frame: Through completion of study (approximately 50 days)

  7. Effect of bright light on wake patterns as measured by PSG

    Time frame: Through completion of study (approximately 50 days)

  8. Effect of bright light on wake patterns as measured by ESS

    Time frame: Through completion of study (approximately 50 days)

  9. Effect of bright light on wake patterns as measured by VAS (daytime sleepiness) in Daily Fatigue and Sleep Log

    Time frame: Through completion of study (approximately 50 days)

  10. Effect of bright light on quality of life as measured by EORCT QLQ C-30

    Time frame: Through completion of study (approximately 50 days)

  11. Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms

    Time frame: Through completion of study (approximately 50 days)

    -Feasibility of the procedures will be assessed by descriptive analysis

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2016
Registry last updated
Sep 25, 2017

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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