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NCT03304587

Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors

Completed NA Results posted Last updated 10 June 2025
What this trial tests

NA trial testing Polysomnography (PSG) in Breast Cancer in 30 participants. Completed in 31 August 2022.

Timeline
6 November 2017
Primary endpoint
31 August 2022
31 August 2022

Quick facts

Lead sponsorMichigan State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment30
Start date6 November 2017
Primary completion31 August 2022
Estimated completion31 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Michigan State University

Who can join

21 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Attrition and Adherence Primary · Up to 3 weeks from registration

Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants wit

Attrition
GroupValue95% CI
Arm 1: Bright Blue-green Light1
Arm 2: Dim Red Light1
Adherence to light therapy
GroupValue95% CI
Arm 1: Bright Blue-green Light14
Arm 2: Dim Red Light14
Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score. A higher PROMIS-Sleep disturbance T-score represents greater\\worse sleep disturbance. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse sleep disturbance Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light56± 6
Arm 2: Dim Red Light57.3± 7.5
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light49.6± 5.3
Arm 2: Dim Red Light50.4± 6
Effects of Bright Light on Sleep Disturbance as Measured by the PSQI Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Pittsburgh Sleep Quality Index (PSQI) Global score: The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light9.3± 3.2
Arm 2: Dim Red Light9.6± 3.2
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light7.8± 2.4
Arm 2: Dim Red Light6.0± 3.1
Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score. A higher PROMIS-Cancer-Fatigue T-score represents greater\\worse fatigue. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse fatigue Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light55.8± 6.8
Arm 2: Dim Red Light56.3± 7.9
Post Test
GroupValue95% CI
Arm 1: Bright Blue-green Light48.3± 4.4
Arm 2: Dim Red Light50.5± 6.4
Effects of Bright Light on Fatigue as Measured by the Daily Log Secondary · Kept throughout the approx 3 weeks of the study

Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue

Baseline self-reported fatigue
GroupValue95% CI
Arm 1: Bright Blue-green Light3.54± 2.03
Arm 2: Dim Red Light4.57± 2.41
Post-Test self-reported fatigue
GroupValue95% CI
Arm 1: Bright Blue-green Light1.92± 1.44
Arm 2: Dim Red Light2.86± 2.35
Effects of Bright Light on Depression as Measured by the PROMIS-Depression Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score. A higher PROMIS-Depression T-score represents greater\\worse Depression. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse worse depression. Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light50.4± 7.9
Arm 2: Dim Red Light51.1± 6.4
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light45.2± 5.9
Arm 2: Dim Red Light46.5± 7.0
Effects of Bright Light on Depression as Measured by the CES-D Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light14.7± 8.3
Arm 2: Dim Red Light16.3± 4.1
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light6.0± 3.8
Arm 2: Dim Red Light8.9± 5.3
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light27.9± 1.7
Arm 2: Dim Red Light26.6± 2.2
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light28.0± 2.0
Arm 2: Dim Red Light27.1± 1.7
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score. A higher PROMIS-Physical Function T-score represents greater\\better Physical Function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean better functioning. Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light47.5± 10.2
Arm 2: Dim Red Light48.6± 8.1
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light48.7± 9.2
Arm 2: Dim Red Light51.3± 8.3
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life

Baseline QOL-Global
GroupValue95% CI
Arm 1: Bright Blue-green Light65.6± 16.6
Arm 2: Dim Red Light76.1± 16.0
Post-Test QOL-Global
GroupValue95% CI
Arm 1: Bright Blue-green Light76.2± 7.9
Arm 2: Dim Red Light81.0± 11
Baseline QOL-Symptom
GroupValue95% CI
Arm 1: Bright Blue-green Light20.7± 13.0
Arm 2: Dim Red Light19.5± 9.0
Post-Test QOL-Symptom
GroupValue95% CI
Arm 1: Bright Blue-green Light13.4± 7.1
Arm 2: Dim Red Light12.1± 7.3
Baseline QOL-Function
GroupValue95% CI
Arm 1: Bright Blue-green Light76.7± 15.7
Arm 2: Dim Red Light80.4± 10.4
Post-Test QOL-Function
GroupValue95% CI
Arm 1: Bright Blue-green Light87.0± 6.6
Arm 2: Dim Red Light87.6± 9.2
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light394.2± 68.9
Arm 2: Dim Red Light393.53± 59.35
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light386.1± 84.8
Arm 2: Dim Red Light415.9± 71.5
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency Secondary · Baseline (day 2 of study) and Post-treatment (approx day 17 of study)

Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time.

Baseline
GroupValue95% CI
Arm 1: Bright Blue-green Light81.9± 7.9
Arm 2: Dim Red Light82.7± 8.08
Post-Test
GroupValue95% CI
Arm 1: Bright Blue-green Light81.0± 14.3
Arm 2: Dim Red Light82.4± 12.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline assessment through post-assessment (up to 3 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Bright Blue-green Light
Serious: 0/15 (0%)
Deaths: 0/15
Arm 2: Dim Red Light
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (1 terms — click to expand)

ReactionSystemArm 1: Bright Blue-green L…Arm 2: Dim Red Light
HeadacheNervous system disorders

Data from ClinicalTrials.gov NCT03304587 adverse events section.

Sponsor's own description

This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluating chronotypically tailored light therapy for breast cancer survivors: Preliminary findings on fatigue and disrupted sleep.
    Wu HS, Gao F, Yan L, Given C. · · 2022 · cited 17× · PMID 34732099 · DOI 10.1080/07420528.2021.1992419
  2. Bright light shows promise in improving sleep, depression, and quality of life in women with breast cancer during chemotherapy: findings of a pilot study.
    Wu HS, Davis JE, Chen L. · · 2021 · cited 16× · PMID 33478260 · DOI 10.1080/07420528.2021.1871914
  3. Effects of chronotype-tailored bright light intervention on post-treatment symptoms and quality of life in breast cancer survivors.
    Wu HS, Gao F, Davis JE, Given CW. · · 2023 · cited 3× · PMID 37975923 · DOI 10.1007/s00520-023-08157-9
  4. Effects of Chronotype-tailored Bright Light Intervention on Symptoms and Quality of Life in Breast Cancer Survivors
    Wu H, Gao F, Davis JE, Given CW. · · 2023 · DOI 10.21203/rs.3.rs-3286350/v1

Verify or expand the search:

Other trials of Polysomnography (PSG)

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Michigan State University trials

Trials by the same sponsor.

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Data sources for this page

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