The "Light for the Brain" Study

Northwestern University

Status: Completed

Conditions: Quality of Life; Hematopoietic Stem Cell Transplantation; Depression; Fatigue; Sleep; Cognitive Impairments

Treatments: Device: Intervention systematic light exposure; Device: Comparison systematic light exposure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02677987

STU00201700

7K07CA184145-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

Intervention light

Experimental group

Description:

30 minutes of intervention systematic light exposure daily for 4 weeks.

Treatment:

Device: Intervention systematic light exposure

Comparison light

Active Comparator group

Description:

30 minutes of comparison systematic light exposure daily for 4 weeks.

Treatment:

Device: Comparison systematic light exposure