Clinical trial NCT02677987: The "Light for the Brain" Study
Official title: Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Cognitive Impairments
Sleep
Depression
Fatigue
Quality of Life
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-09
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Cognitive Functioning (Neuropsychological Tests)
timeFrame: Baseline to end-of-intervention to 8 weeks after the intervention
Secondary outcomes:
measure: Circadian Activity Rhythms (Actigraphy)
timeFrame: Baseline to end of intervention to 8 weeks later
measure: Sleep Quality (Pittsburgh Sleep Quality Index)
timeFrame: Baseline, mid intervention, end of intervention, 8 weeks later
measure: Fatigue (FACIT-fatigue)
timeFrame: Baseline, mid-intervention, end of the intervention, 8 weeks later
measure: Depressed Mood (CESD)
timeFrame: Baseline, Mid-intervention, End of intervention, 8 weeks later
measure: Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
timeFrame: Baseline, mid-intervention, end-of-intervention, 8 weeks later
measure: Quality of Life (FACT-BMT)
timeFrame: Baseline, End of intervention, 8 weeks post-intervention
measure: Interleukin-6
timeFrame: Baseline and end-of-intervention
measure: Pro-inflammatory Cytokine - TNF Alpha
timeFrame: Baseline and end-of-intervention
measure: C-Reactive Protein
timeFrame: Baseline and end-of-intervention
measure: Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
timeFrame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention
Other outcomes:
measure: Treatment Satisfaction (FACT-TS)
timeFrame: During the 4th week of the intervention
measure: Credibility/Expectancy (Credibility/Expectancy Questionnaire)
timeFrame: Baseline
measure: Usage of Light Box (Integrated Meter Measurement and Litebook Log)
timeFrame: Throughout intervention period (4 weeks)
measure: Chronotype (Morningness-eveningness Questionnaire)
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lisa M Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.