Systematic Light Exposure for Fatigue in Breast Cancer Patients
Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients
2 other identifiers
interventional
194
1 country
3
Brief Summary
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 Memorial Sloan Kettering Cancer Center, and City of Hope. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
3 active sites
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
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
January 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedAugust 23, 2023
August 1, 2023
4 years
July 11, 2017
August 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FACIT-Fatigue Scale
FACIT-Fatigue Scale - The FACIT-Fatigue scale will be used both for selection of patients into the study and as an outcome measure of fatigue. Smith et al. (1999) report that this 13 item scale has excellent test-retest reliability (r = 0.90) and internal consistency reliability (alpha = 0.93-0.95). In addition, criterion related validity studies using objective measures of physical function as the outcome show that patient reported fatigue based on the FACIT- Fatigue can predict these objective measures. This measure is the main tool for measuring fatigue in the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. Cella (personal communication) has indicated that a FACIT-Fatigue score equal to or less than 33 constitutes clinically significant fatigue.
up to 6 months
Secondary Outcomes (4)
The Center for Epidemiological Studies Depression Scale (CES-D)
up to 6 months
The Pittsburgh Sleep Quality Index
up to 6 months
Chronotype (MEQ)
up to 6 months
Credibility/Expectancy Questionnaire
up to 6 months
Study Arms (4)
Adjuvant, Experimental Light
EXPERIMENTAL30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Adjuvant, Comparison Light
ACTIVE COMPARATOR30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Neo-Adjuvant, Experimental Light
EXPERIMENTAL30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Neo-Adjuvant, Comparison Light
ACTIVE COMPARATOR30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Interventions
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
Eligibility Criteria
You may qualify if:
- 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, neoadjuvant, or already receiving chemotherapy.
- MSH, COH and MSK can recruit participants schedule to go on aromatase inhibitors after treatment.
- Currently over the age of 18.
- English language proficient.
- Able to provide informed consent.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- Memorial Sloan Kettering Cancer Centercollaborator
- National Cancer Institute (NCI)collaborator
- City of Hope Medical Centercollaborator
Study Sites (3)
City of Hope Cancer Center
Duarte, California, 91010, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (2)
Rotonda C, Guillemin F, Bonnetain F, Velten M, Conroy T. Factors associated with fatigue after surgery in women with early-stage invasive breast cancer. Oncologist. 2013;18(4):467-75. doi: 10.1634/theoncologist.2012-0300. Epub 2013 Feb 12.
PMID: 23404818BACKGROUNDMinton O, Stone P. How common is fatigue in disease-free breast cancer survivors? A systematic review of the literature. Breast Cancer Res Treat. 2008 Nov;112(1):5-13. doi: 10.1007/s10549-007-9831-1. Epub 2007 Dec 7.
PMID: 18064565BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William H. Redd, Ph.D.
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant does not know his or her study condition.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 14, 2017
Study Start
January 25, 2018
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
August 23, 2023
Record last verified: 2023-08