Clinical trial · Interventional
Bright Light on Fatigue in Women Being Treated for Breast Cancer
Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
NCT02658708CI-TRIAL-00029637completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bright blue-green light using light visor cap | Other | — | UNRESOLVED |
| Daily Fatigue and Sleep Log | Other | — | UNRESOLVED |
| Digital foot candle datalogging light meter (Extech Instrument, Model SDL400) | Diagnostic Test | — | UNRESOLVED |
| Dim red light using light visor cap | Other | — | UNRESOLVED |
| Epworth Sleepiness Scale | Other | — | UNRESOLVED |
| European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire | Other | — | UNRESOLVED |
| Horne-Ostberg Morningness-Eveningness Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Bright blue-green light
- 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
- interventionNames
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDWu 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