Systematic Light Exposure for Fatigue in Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:January 25, 2018
End Date:April 30, 2022
Contact:Kathryn Sommer, BS
Email:kathryn.sommer@mssm.edu
Phone:212-659-5645

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Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients

Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or
its treatment. CRF is the most intense during treatment and can severely interfere with
activities of daily living, such as tasks that require physical strength or thinking clearly.
Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as
34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008).
There is currently no generally-accepted treatment for CRF. However, there is evidence to
suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have
also been studied but are costly to implement and involve significant patient burden,
particularly among those in active treatment. Given the clinical impact of CRF, the goal of
this project is to investigate a novel, low-cost and low-burden intervention for Breast
Cancer patients using a particular kind of light treatment called systematic light exposure
(sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant
or neoadjuvant chemotherapy will be recruited from Mount Sinai Medical Center, Memorial Sloan
Kettering Cancer Center, and Hackensack University Medical Center. The light will be
administered by light glasses daily throughout entire duration of chemotherapy. Outcomes will
be assessed at eight timepoints during chemo, and a series of follow up assessments at 1
week, 1-month, 3-months and 6-months post-chemotherapy. This study will have major public
health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient
burden intervention effectively reduces CRF or prevents it from worsening during
chemotherapy. Specific Aims: Aim 1: Determine if sLE prevents CRF from worsening in BC
patients undergoing chemotherapy Aim 2: Determine whether sLE affects sleep, depression and
circadian activity rhythms. Exploratory Aim 3: Investigate sLE normalizes circadian cortisol
rhythms. Exploratory Aim 4: Examine whether the effects of sLE on fatigue are
moderated/mediated by sleep quality, depression, and/or circadian rhythms.


Inclusion Criteria:

- Newly diagnosed patients with stage 1 through 3a Breast Cancer scheduled to receive a
12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen, adjuvant or
neoadjuvant.

- Currently over the age of 18.

- English language proficient

- Able to provide informed consent

Exclusion Criteria:

- Under age 18

- Breast cancer patients scheduled to undergo chemo regimen other than the 12-week,
18-week, 20-week, or 24-week regimen

- Stage 3B breast cancer inflammatory or Stage 4 breast cancer

- Breast cancer patients scheduled to go on aromatase inhibitors after treatment (Note:
at Mount Sinai Hospital only, there is another ongoing Breast Cancer R01 and in order
to avoid conflicting with that protocol and overburdening patients, this project will
exclude BC patients scheduled to go on aromatase inhibitors. The study team can easily
reach recruitment goals with this approach)

- Pregnancy

- Currently employed in night shift work

- Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia
not controlled by medication, per self-report corroborated by medical chart review
(e.g., Hb<10gm/dl))

- Eye Diseases which limit the ability of light to be processed (e.g., untreated
cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems
or retina damage)

- Secondary cancer diagnosis (prior or current) within the past 5 years

- Severe sleep disorders (e.g., Narcolepsy)

- Self- reported history of bipolar disorder or manic episodes (which is a
contra-indication for light treatment)

- Severe psychological impairment (e.g., hospitalization for depressive episode in the
past 12 months

- Previous use of light therapy to alleviate fatigue or depressive symptoms

- Lives outside of the United States throughout the duration of study
We found this trial at
3
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Wendy Lichtenthal, PhD
Phone: 212-639-7592
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Christine Rini, PhD
Phone: 551-996-4152
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: William H. Redd, Ph.D.
Phone: 212-659-5645
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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