Effect of Increased Light Exposure on Fatigue in Breast Cancer
1 other identifier
interventional
39
1 country
1
Brief Summary
Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In addition, chemotherapy disrupts the body's internal "biological clock", which may make sleep, fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not exposed to much bright light and this may also contribute to the disruption of their body clock, because bright light is necessary for a strong biological clock. One of the easiest ways to strengthen the biological clock is by increasing bright light exposure. The correct timing of the light exposure will help the women feel more alert during the day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Nov 2005
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 16, 2016
CompletedFebruary 6, 2019
January 1, 2019
4 years
May 22, 2007
June 18, 2012
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue
The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.
four cycles of chemotherapy
Study Arms (2)
1 Active Bright White Light Treatment
ACTIVE COMPARATORIntervention: Bright white light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy
2 Comparator Red Light Treatment
ACTIVE COMPARATORIntervention: Dim red light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy
Interventions
Intervention: Bright white light administered for 30 minutes each morning
dim red light administered for 30 minutes every morning
Eligibility Criteria
You may qualify if:
- stage I-III breast cancer
- adjuvant or neoadjuvant anthracycline-based chemotherapy
You may not qualify if:
- under age 18
- pregnancy
- metastatic or inoperable (including inflammatory) breast cancer
- confounding underlying medical illnesses
- history of mania
- history of other axis-I psychiatric disorder
- other physical or psychological impairments -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moores UCSD Cancer Center
San Diego, California, 92093, United States
Related Publications (4)
Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-011-1203-z. Epub 2011 Jun 11.
PMID: 21660669RESULTJeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 2013 Aug;22(6):1239-44. doi: 10.1007/s11136-012-0243-2. Epub 2012 Aug 3.
PMID: 22865153RESULTNeikrug AB, Rissling M, Trofimenko V, Liu L, Natarajan L, Lawton S, Parker BA, Ancoli-Israel S. Bright light therapy protects women from circadian rhythm desynchronization during chemotherapy for breast cancer. Behav Sleep Med. 2012;10(3):202-16. doi: 10.1080/15402002.2011.634940.
PMID: 22742438RESULTRissling M, Liu L, Youngstedt SD, Trofimenko V, Natarajan L, Neikrug AB, Jeste N, Parker BA, Ancoli-Israel S. Preventing Sleep Disruption With Bright Light Therapy During Chemotherapy for Breast Cancer: A Phase II Randomized Controlled Trial. Front Neurosci. 2022 Mar 9;16:815872. doi: 10.3389/fnins.2022.815872. eCollection 2022.
PMID: 35356054DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size; only partial compliance data; light only administered in morning; only tested effect in patients with breast cancer.
Results Point of Contact
- Title
- Dr. Sonia Ancoli-Israel
- Organization
- UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Ancoli-Israel, PhD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 24, 2007
Study Start
November 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
February 6, 2019
Results First Posted
June 16, 2016
Record last verified: 2019-01