Clinical trial NCT02658708: Bright Light on Fatigue in Women Being Treated for Breast Cancer
Official title: Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Breast Cancer
Cancer of Breast
Cancer of the Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 19
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log
timeFrame: Through of completion of study (approximately 43 days)
measure: Effect of bright light on sleep patterns as measured by PSG
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance
timeFrame: Through of completion of study (approximately 43 days)
measure: Effect of bight light on sleep patterns as measured by PSQI
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on wake patterns as measured by PSG
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on wake patterns as measured by ESS
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on wake patterns as measured by VAS (daytime sleepiness) in Daily Fatigue and Sleep Log
timeFrame: Through completion of study (approximately 50 days)
measure: Effect of bright light on quality of life as measured by EORCT QLQ C-30
timeFrame: Through completion of study (approximately 50 days)
measure: Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms
timeFrame: Through completion of study (approximately 50 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Horng-Shiuann Wu, Ph.D., R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.