Bright Light on Fatigue in Women Being Treated for Breast Cancer

NCT02658708 | Completed Phase 1

• 1 other identifier: 201503075
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms; Breast Cancer; Cancer of Breast; Cancer of the Breast

Outcome Measures

Primary Outcomes (11)

• 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)

Study Arms (2)

Arm 1: Bright blue-green light

EXPERIMENTAL

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; 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

Arm 2: Dim red light

ACTIVE COMPARATOR

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: Dim red 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

Interventions

Bright blue-green light using light visor cap OTHER

Arm 1: Bright blue-green light

Dim red light using light visor cap OTHER

Arm 2: Dim red light

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

Also known as: EORCT QLQ C-30

Arm 1: Bright blue-green light; Arm 2: Dim red light

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

Also known as: ESS

Arm 1: Bright blue-green light; Arm 2: Dim red light

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

Also known as: PSQI

Arm 1: Bright blue-green light; Arm 2: Dim red light

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

Arm 1: Bright blue-green light; Arm 2: Dim red light

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.

Arm 1: Bright blue-green light; Arm 2: Dim red light

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.

Arm 1: Bright blue-green light; Arm 2: Dim red light

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

Also known as: PSG

Arm 1: Bright blue-green light; Arm 2: Dim red light

Horne-Ostberg Morningness-Eveningness Questionnaire OTHER

Also known as: MEQ

Arm 1: Bright blue-green light; Arm 2: Dim red light

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)

Arm 1: Bright blue-green light; Arm 2: Dim red light

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 33478260 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Horng-Shiuann Wu, Ph.D., R.N.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 20, 2016
• Study Start: October 12, 2015
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)