Bright Light on Fatigue in Women Being Treated for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658708
• Other study ID #: 201503075
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2016
• Last updated: September 22, 2017
• Start date: October 12, 2015
• Est. completion date: May 9, 2017

Study information

• Verified date: September 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of Breast
• Cancer of the Breast
• Fatigue

Intervention

Other:
• Bright blue-green light using light visor cap

• Dim red light using light visor cap

• 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
• 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
• 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
• 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
• 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.
• 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:
• Horne-Ostberg Morningness-Eveningness Questionnaire

• 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)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue		Through completion of study (approximately 50 days)
Primary	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)
Primary	Effect of bright light on sleep patterns as measured by PSG		Through completion of study (approximately 50 days)
Primary	Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance		Through of completion of study (approximately 43 days)
Primary	Effect of bight light on sleep patterns as measured by PSQI		Through completion of study (approximately 50 days)
Primary	Effect of bright light on wake patterns as measured by PSG		Through completion of study (approximately 50 days)
Primary	Effect of bright light on wake patterns as measured by ESS		Through completion of study (approximately 50 days)
Primary	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)
Primary	Effect of bright light on quality of life as measured by EORCT QLQ C-30		Through completion of study (approximately 50 days)
Primary	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)

External Links

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