Bright Light on Fatigue in Women Being Treated for Breast Cancer

Phase 1

Completed

• Conditions: Breast Neoplasms; Cancer of Breast; Breast Cancer; Cancer of the Breast

• Registration Number: NCT02658708
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of bright light on sleep patterns as measured by PSG	Through completion of study (approximately 50 days)
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording	Through completion of study (approximately 50 days)	-Feasibility of the procedures will be assessed by descriptive analysis
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 PROMIS-Sleep Disturbance	Through of completion of study (approximately 43 days)
Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms	Through completion of study (approximately 50 days)	-Feasibility of the procedures will be assessed by descriptive analysis
Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue	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 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 quality of life as measured by EORCT QLQ C-30	Through completion of study (approximately 50 days)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States