N/A
N=47
The "Light for the Brain" Study
Hematopoietic Stem Cell Transplantation · Cognitive Impairments · Sleep · Depression · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT02677987 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Cognitive Functioning (Neuropsychological Tests) — 0.24; 0.16; 0.43; 0.50 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention systematic light exposure (Device); Comparison systematic light exposure (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Functioning (Neuropsychological Tests) |
0.24; 0.16; 0.43; 0.50 | — |
| SECONDARY Circadian Activity Rhythms (Actigraphy) |
1696.19; 1551.72; 1999.72; 1373.88; 1858.04; 1466.82 | — |
| SECONDARY Sleep Quality (Pittsburgh Sleep Quality Index) |
7.3157; 8.5000; 6.7500; 7.7500; 6.5296; 7.5500 | — |
| SECONDARY Fatigue (FACIT-fatigue) |
29.9804; 30.0000; 29.5833; 33.6356; 30.8219; 33.7513 | — |
| SECONDARY Depressed Mood (CESD) |
18.6293; 20.4500; 20.4583; 18.1000; 19.1489; 17.0500 | — |
| SECONDARY Neurobehavioral Functioning (Frontal Systems Behavioral Scale) |
91.39; 89.36; 92.96; 90.55; 89.04; 88.90 | — |
| SECONDARY Quality of Life (FACT-BMT) |
110.27; 109.66; 116.88; 111.94; 112.68; 110.92 | — |
| SECONDARY Interleukin-6 |
3.24; 3.24; 3.98; 3.28 | — |
| SECONDARY Pro-inflammatory Cytokine - TNF Alpha |
7.55; 7.00; 7.44; 7.30 | — |
| SECONDARY C-Reactive Protein |
5.67; 3.68; 5.95; 3.53 | — |
| SECONDARY Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) |
8.5217; 7.9703; 6.5927; 6.9583; 4.7065; 5.5905 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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,
- 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.
Data sourced from ClinicalTrials.gov (NCT02677987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.