Bright Light on Fatigue in Women Being Treated for Breast Cancer
Status and phase
Completed
Phase 1
Conditions
Cancer of Breast
Breast Cancer
Cancer of the Breast
Breast Neoplasms
Treatments
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
Other: Daily Fatigue and Sleep Log
Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
Other: Pittsburgh Sleep Quality Index
Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
Other: Bright blue-green light using light visor cap
Other: Horne-Ostberg Morningness-Eveningness Questionnaire
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
Other: Dim red light using light visor cap
Other: Epworth Sleepiness Scale
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
Details and patient eligibility
About
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.
Enrollment
19 patients
Sex
Female
Ages
21+ years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
19 participants in 2 patient groups
Arm 1: Bright blue-green light
Experimental group
Description:
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
Treatment:
Other: Epworth Sleepiness Scale
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
Other: Horne-Ostberg Morningness-Eveningness Questionnaire
Other: Daily Fatigue and Sleep Log
Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
Other: Bright blue-green light using light visor cap
Other: Pittsburgh Sleep Quality Index
Arm 2: Dim red light
Active Comparator group
Description:
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
Treatment:
Other: Epworth Sleepiness Scale
Other: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue
Other: Horne-Ostberg Morningness-Eveningness Questionnaire
Other: Daily Fatigue and Sleep Log
Diagnostic Test: Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)
Other: Dim red light using light visor cap
Diagnostic Test: Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)
Other: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance
Other: Pittsburgh Sleep Quality Index
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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