The "Light for the Brain" Study

NCT ID: NCT02677987

Last Updated: 2022-04-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention light

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

Group Type EXPERIMENTAL

Intervention systematic light exposure

Intervention Type DEVICE

Bright light using Litebook device.

Comparison light

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

Group Type ACTIVE_COMPARATOR

Comparison systematic light exposure

Intervention Type DEVICE

Dim light using modified Litebook device.

Interventions

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Intervention systematic light exposure

Bright light using Litebook device.

Intervention Type DEVICE

Comparison systematic light exposure

Dim light using modified Litebook device.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Lisa M. Wu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa M Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35904252 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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7K07CA184145-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00201700

Identifier Type: -

Identifier Source: org_study_id

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