Hematopoietic Stem Cell TransplantationNCT02677987
The "Light for the Brain" Study
A study testing Intervention systematic light exposure and Comparison systematic light exposure in people with Hematopoietic Stem Cell Transplantation and Cognitive Impairments, run by Northwestern University at 1 site in United States.
Trial summary
Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep
- What is being tested?
- Intervention systematic light exposure and Comparison systematic light exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a history of HSCT,
- 1 to 5 years post-HSCT,
- Relapse-free since most recent HSCT,
- Age 21 or older,
- English language proficient
- Able to provide informed consent
- Endorse subjective cognitive impairment.
Who cannot join
- Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment),
- Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,
- Have a history of whole brain irradiation or surgery,
- Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,
- Chronic use of oral steroid medication,
- History of systematic light exposure treatment,
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- Diagnosed sleep apnea or narcolepsy,
- Use of photosensitizing medications,
- Plan to travel across meridians during the study,
- Work night, early morning, or swing shifts,
- Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.
- Conditions
- Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep, Depression, Fatigue, Quality of Life
- Being tested
- Intervention systematic light exposure, Comparison systematic light exposure
- Medical subject headings
- Cognitive Dysfunction, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention systematic light exposureDevice
Bright light using Litebook device.
Comparison systematic light exposureDevice
Dim light using modified Litebook device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention light | Experimental | 30 minutes of intervention systematic light exposure daily for 4 weeks. Receives: Device: Intervention systematic light exposure |
| Comparison light | Active comparator | 30 minutes of comparison systematic light exposure daily for 4 weeks. Receives: Device: Comparison systematic light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functioning (Neuropsychological Tests)
Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III.
Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores.
A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.
Measured: Baseline to end-of-intervention to 8 weeks after the intervention
Secondary outcomes (10)
Circadian Activity Rhythms (Actigraphy)
F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Measured: Baseline to end of intervention to 8 weeks later
Sleep Quality (Pittsburgh Sleep Quality Index)
The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Measured: Baseline, mid intervention, end of intervention, 8 weeks later
Fatigue (FACIT-fatigue)
This is a 13-item measure of fatigue.
Measured: Baseline, mid-intervention, end of the intervention, 8 weeks later
Depressed Mood (CESD)
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.
Measured: Baseline, Mid-intervention, End of intervention, 8 weeks later
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
Measured: Baseline, mid-intervention, end-of-intervention, 8 weeks later
Quality of Life (FACT-BMT)
This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).
Measured: Baseline, End of intervention, 8 weeks post-intervention
Interleukin-6
Serum cytokine IL-6 in pg/mL
Measured: Baseline and end-of-intervention
Pro-inflammatory Cytokine - TNF Alpha
Serum cytokine TNF-α in pg/mL
Measured: Baseline and end-of-intervention
C-Reactive Protein
C-reactive protein in mg/L
Measured: Baseline and end-of-intervention
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.
Measured: Baseline, mid-intervention, end of intervention, 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lisa M. Wu, Northwestern University
- Investigators
- Lisa M Wu, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677987
- Sponsor's protocol ID
- STU00201700
- Other IDs
- 7K07CA184145-02
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2016
- Last updated
- 18 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu LM, Valdimarsdottir HB, Amidi A, Reid KJ, Ancoli-Israel S, Bovbjerg K, Fox RS, Walker L, Matharu A, Kaseda ET, Galvin JP, Adekola K, Winkel G, Penedo F, Redd WH. Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors. J Biol Rhythms. 2022 Oct;37(5):471-483. doi: 10.1177/07487304221107833. Epub 2022 Jul 29.
PubMed 35904252
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
- ClinicalTrials.gov ID
- NCT02677987
- Acronym / sponsor ID
- STU00201700
- Conditions
- Hematopoietic Stem Cell Transplantation, Cognitive Impairments, Sleep, Depression, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 18 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention light | Experimental | Device: Intervention systematic light exposure30 minutes of intervention systematic light exposure daily for 4 weeks. |
| Comparison light | Active comparator | Device: Comparison systematic light exposure30 minutes of comparison systematic light exposure daily for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a history of HSCT,
- 1 to 5 years post-HSCT,
- Relapse-free since most recent HSCT,
- Age 21 or older,
- English language proficient
Key exclusion criteria (11 listed)
- Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment),
- Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,
- Have a history of whole brain irradiation or surgery,
- Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,
- Chronic use of oral steroid medication,
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 |
|---|---|---|
| Intervention systematic light exposureBright light using Litebook device. | Device | Intervention light |
| Comparison systematic light exposureDim light using modified Litebook device. | Device | Comparison light |
Primary outcome
Cognitive Functioning (Neuropsychological Tests)
Time frame: Baseline to end-of-intervention to 8 weeks after the intervention
Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.
10 secondary outcomes
Circadian Activity Rhythms (Actigraphy)
Time frame: Baseline to end of intervention to 8 weeks later
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline, mid intervention, end of intervention, 8 weeks later
Fatigue (FACIT-fatigue)
Time frame: Baseline, mid-intervention, end of the intervention, 8 weeks later
Depressed Mood (CESD)
Time frame: Baseline, Mid-intervention, End of intervention, 8 weeks later
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Time frame: Baseline, mid-intervention, end-of-intervention, 8 weeks later
Quality of Life (FACT-BMT)
Time frame: Baseline, End of intervention, 8 weeks post-intervention
Interleukin-6
Time frame: Baseline and end-of-intervention
Pro-inflammatory Cytokine - TNF Alpha
Time frame: Baseline and end-of-intervention
C-Reactive Protein
Time frame: Baseline and end-of-intervention
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
Time frame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35904252Wu LM, Valdimarsdottir HB, Amidi A, Reid KJ, Ancoli-Israel S, Bovbjerg K, Fox RS, Walker L, Matharu A, Kaseda ET, Galvin JP, Adekola K, Winkel G, Penedo F, Redd WH. Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors. J Biol Rhythms. 2022 Oct;37(5):471-483. doi: 10.1177/07487304221107833. Epub 2022 Jul 29.
- 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.
Lisa M Wu, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention systematic light exposure and Comparison systematic light exposure in people with Hematopoietic Stem Cell Transplantation and Cognitive Impairments, run by Northwestern University 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 7 inclusion and 11 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 18 Apr 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cognitive Functioning (Neuropsychological Tests) (time frame: Baseline to end-of-intervention to 8 weeks after the intervention). 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 NCT02677987, 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 18 Apr 2022.