The "Light for the Brain" Study

Not Applicable

Completed

• Conditions: Quality of Life; Hematopoietic Stem Cell Transplantation; Cognitive Impairments; Depression; Fatigue; Sleep
• Interventions: Device: Intervention systematic light exposure; Device: Comparison systematic light exposure

• Registration Number: NCT02677987
• Lead Sponsor: Northwestern University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Study Start: 2016-04
• Primary Completion: 2019-10
• Study Completion: 2021-03
• Results First Submitted: 2022-02-07
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Results First Posted: 2022-04-18
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. Have a history of HSCT,
2. 1 to 5 years post-HSCT,
3. Relapse-free since most recent HSCT,
4. Age 21 or older,
5. English language proficient
6. Able to provide informed consent
7. Endorse subjective cognitive impairment.

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Exclusion Criteria

1. 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),
2. Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,
3. Have a history of whole brain irradiation or surgery,
4. Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,
5. Chronic use of oral steroid medication,
6. History of systematic light exposure treatment,
7. Diagnosed sleep apnea or narcolepsy,
8. Use of photosensitizing medications,
9. Plan to travel across meridians during the study,
10. Work night, early morning, or swing shifts,
11. Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention light	Intervention systematic light exposure	30 minutes of intervention systematic light exposure daily for 4 weeks.
Comparison light	Comparison systematic light exposure	30 minutes of comparison systematic light exposure daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Cognitive Functioning (Neuropsychological Tests)	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.

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	Baseline and end-of-intervention	Serum cytokine IL-6 in pg/mL
C-Reactive Protein	Baseline and end-of-intervention	C-reactive protein in mg/L
Circadian Activity Rhythms (Actigraphy)	Baseline to end of intervention to 8 weeks later	F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Depressed Mood (CESD)	Baseline, Mid-intervention, End of intervention, 8 weeks later	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.
Pro-inflammatory Cytokine - TNF Alpha	Baseline and end-of-intervention	Serum cytokine TNF-α in pg/mL
Fatigue (FACIT-fatigue)	Baseline, mid-intervention, end of the intervention, 8 weeks later	This is a 13-item measure of fatigue.
Sleep Quality (Pittsburgh Sleep Quality Index)	Baseline, mid intervention, end of intervention, 8 weeks later	The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Quality of Life (FACT-BMT)	Baseline, End of intervention, 8 weeks post-intervention	This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)	Baseline, mid-intervention, end-of-intervention, 8 weeks later	Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)	Baseline, mid-intervention, end of intervention, 8 weeks after intervention	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.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States