Bright Light on Fatigue in Women Being Treated for Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms; Cancer of Breast; Cancer of the Breast
• Intervention / Treatment: Other: Bright blue-green light using light visor cap; Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire; Other: Epworth Sleepiness Scale; Other: Pittsburgh Sleep Quality Index; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue; Diagnostic test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400); Diagnostic test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA); Other: Horne-Ostberg Morningness-Eveningness Questionnaire; Other: Daily Fatigue and Sleep Log; Other: Dim red light using light visor cap

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Bright blue-green light; Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, -21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed	Other: Bright blue-green light using light visor cap; Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire; -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; Other: Epworth Sleepiness Scale; -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; Other: Pittsburgh Sleep Quality Index; -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; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance; -Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue; -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.; Diagnostic test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400); -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.; Diagnostic test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA); -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; Other: Horne-Ostberg Morningness-Eveningness Questionnaire; Other Names: MEQ; Other: Daily Fatigue and Sleep Log; 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)
Active Comparator: Arm 2: Dim red light; Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, 21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 days randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed	Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire; -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; Other: Epworth Sleepiness Scale; -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; Other: Pittsburgh Sleep Quality Index; -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; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance; -Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances; Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue; -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.; Diagnostic test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400); -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.; Diagnostic test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA); -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; Other: Horne-Ostberg Morningness-Eveningness Questionnaire; Other Names: MEQ; Other: Daily Fatigue and Sleep Log; 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); Other: Dim red light using light visor cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording	-Feasibility of the procedures will be assessed by descriptive analysis	Through completion of study (approximately 50 days)
Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue		Through completion of study (approximately 50 days)
Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log		Through of completion of study (approximately 43 days)
Effect of bright light on sleep patterns as measured by PSG		Through completion of study (approximately 50 days)
Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance		Through of completion of study (approximately 43 days)
Effect of bight light on sleep patterns as measured by PSQI		Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by PSG		Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by ESS		Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by VAS (daytime sleepiness) in Daily Fatigue and Sleep Log		Through completion of study (approximately 50 days)
Effect of bright light on quality of life as measured by EORCT QLQ C-30		Through completion of study (approximately 50 days)
Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms	-Feasibility of the procedures will be assessed by descriptive analysis	Through completion of study (approximately 50 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Horng-Shiuann Wu, Ph.D., R.N., Washington University School of Medicine

Publications and helpful links

General Publications

• Wu HS, Davis JE, Chen L. Bright light shows promise in improving sleep, depression, and quality of life in women with breast cancer during chemotherapy: findings of a pilot study. Chronobiol Int. 2021 May;38(5):694-704. doi: 10.1080/07420528.2021.1871914. Epub 2021 Jan 21.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2015
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): May 9, 2017

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201503075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No