Breast NeoplasmsPhase 1NCT02658708
Bright Light on Fatigue in Women Being Treated for Breast Cancer
A Phase 1 study testing Bright blue-green light using light visor cap, Dim red light using light visor cap and European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire in people with Breast Neoplasms and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, Cancer of Breast
- What is being tested?
- Bright blue-green light using light visor cap, Dim red light using light visor cap and European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2015to 9 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
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.
- Being tested
- Bright blue-green light using light visor cap, Dim red light using light visor cap, European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright blue-green light using light visor capOther
Dim red light using light visor capOther
European Organization for Research and Treatment of Cancer-Quality of Life QuestionnaireOther
Also called EORCT QLQ C-30
-Consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life
Epworth Sleepiness ScaleOther
Also called ESS
-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period
Pittsburgh Sleep Quality IndexOther
Also called PSQI
-Contains 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep DisturbanceOther
-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-FatigueOther
-Consists of 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue.
Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)Diagnostic test
-The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)Diagnostic test
Also called PSG
-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed
Horne-Ostberg Morningness-Eveningness QuestionnaireOther
Also called MEQ
Daily Fatigue and Sleep LogOther
- Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
- Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Bright blue-green light | Experimental | 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 Receives: 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); Other: Horne-Ostberg Morningness-Eveningness Questionnaire; Other: Daily Fatigue and Sleep Log |
| Arm 2: Dim red light | Active comparator | 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 Receives: Other: Dim red 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); Other: Horne-Ostberg Morningness-Eveningness Questionnaire; Other: Daily Fatigue and Sleep Log |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording
-Feasibility of the procedures will be assessed by descriptive analysis
Measured: Through completion of study (approximately 50 days)
Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue
Measured: Through completion of study (approximately 50 days)
Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log
Measured: Through of completion of study (approximately 43 days)
Effect of bright light on sleep patterns as measured by PSG
Measured: Through completion of study (approximately 50 days)
Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance
Measured: Through of completion of study (approximately 43 days)
Effect of bight light on sleep patterns as measured by PSQI
Measured: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by PSG
Measured: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by ESS
Measured: 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
Measured: Through completion of study (approximately 50 days)
Effect of bright light on quality of life as measured by EORCT QLQ C-30
Measured: Through completion of study (approximately 50 days)
Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms
-Feasibility of the procedures will be assessed by descriptive analysis
Measured: Through completion of study (approximately 50 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start12 Oct 2015
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horng-Shiuann Wu, Ph.D., R.N., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658708
- Sponsor's protocol ID
- 201503075
- Status last verified
- Sep 2017
- First submitted
- 6 Jan 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33478260
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02658708
- Acronym / sponsor ID
- 201503075
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Bright blue-green light | Experimental | 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), Other: Horne-Ostberg Morningness-Eveningness Questionnaire, Other: Daily Fatigue and Sleep LogComplete 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 |
| Arm 2: Dim red light | Active comparator | Other: Dim red 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), Other: Horne-Ostberg Morningness-Eveningness Questionnaire, Other: Daily Fatigue and Sleep LogComplete 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright blue-green light using light visor cap | Other | Arm 1: Bright blue-green light |
| Dim red light using light visor cap | Other | Arm 2: Dim red light |
| European Organization for Research and Treatment of Cancer-Quality of Life QuestionnaireAlso: EORCT QLQ C-30-Consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Epworth Sleepiness ScaleAlso: ESS-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Pittsburgh Sleep Quality IndexAlso: PSQI-Contains 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue-Consists of 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)-The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck. | Diagnostic test | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)Also: PSG-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed | Diagnostic test | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Horne-Ostberg Morningness-Eveningness QuestionnaireAlso: MEQ | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
| Daily Fatigue and Sleep Log* Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness * Two 0-10 point rating scales (average and worst fatigue levels in 24 hours) | Other | Arm 1: Bright blue-green light, Arm 2: Dim red light |
Primary outcome
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording
Time frame: 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
Time frame: Through completion of study (approximately 50 days)
Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log
Time frame: Through of completion of study (approximately 43 days)
Effect of bright light on sleep patterns as measured by PSG
Time frame: Through completion of study (approximately 50 days)
Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance
Time frame: Through of completion of study (approximately 43 days)
Effect of bight light on sleep patterns as measured by PSQI
Time frame: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by PSG
Time frame: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by ESS
Time frame: 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
Time frame: Through completion of study (approximately 50 days)
Effect of bright light on quality of life as measured by EORCT QLQ C-30
Time frame: Through completion of study (approximately 50 days)
Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms
Time frame: Through completion of study (approximately 50 days)
-Feasibility of the procedures will be assessed by descriptive analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 33478260Wu 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horng-Shiuann Wu, Ph.D., R.N. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bright blue-green light using light visor cap, Dim red light using light visor cap and European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire in people with Breast Neoplasms and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording (time frame: Through completion of study (approximately 50 days)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.