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Systematic Light Exposure for Fatigue in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217201
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
City of Hope Medical Center
Information provided by (Responsible Party):
William H. Redd, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Fatigue Circadian Rhythm Disorders Device: Light Glasses (Experimental) Device: Light Glasses (Comparison) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stratified by adjuvant and neoadjuvant chemotherapy treatments, then randomly assigned to one of two light treatment conditions.
Masking: Single (Participant)
Masking Description: The participant does not know his or her study condition.
Primary Purpose: Supportive Care
Official Title: Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Adjuvant, Experimental Light
30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Device: Light Glasses (Experimental)
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.

Active Comparator: Adjuvant, Comparison Light
30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Device: Light Glasses (Comparison)
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.

Experimental: Neo-Adjuvant, Experimental Light
30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Device: Light Glasses (Experimental)
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.

Active Comparator: Neo-Adjuvant, Comparison Light
30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Device: Light Glasses (Comparison)
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.




Primary Outcome Measures :
  1. FACIT-Fatigue Scale [ Time Frame: up to 6 months ]
    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.


Secondary Outcome Measures :
  1. The Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: up to 6 months ]
    The Center for Epidemiological Studies Depression Scale (CES-D) - This 20 item self-report adult instrument is designed to measure common symptoms of depression that have occurred over the past week such as poor appetite, hopelessness, pessimism, and fatigue. Internal consistency using coefficient alpha is estimated to be 0.85 for the general, healthy population, and 0.90 among depressed patient samples.

  2. The Pittsburgh Sleep Quality Index [ Time Frame: up to 6 months ]
    The Pittsburgh Sleep Quality Index consists of 19 self-rated items. Scale reliability is excellent using both an internal consistency criterion (Cronbach's alpha = 0.83) and test-retest reliability (r = 0.85). The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).

  3. Chronotype (MEQ) [ Time Frame: up to 6 months ]
    The study team will collect data on baseline circadian predispositions using the Morningness-Eveningness Questionnaire, a 19-item self-rated survey designed to measure whether a person's peak alertness is in the morning or the evening. Takes approximately 2 minutes to complete.

  4. Credibility/Expectancy Questionnaire [ Time Frame: up to 6 months ]
    This questionnaire will ask the patient to report whether the patient feels the light box is a useful treatment for CRF. Patient Assessment of Own Functioning Inventory (PAOFI) a 33-item self- report measure of a patient's self-perceptions regarding their functioning in everyday tasks and activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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, neoadjuvant, or already receiving chemotherapy.
  • 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. Patients at COH and MSK scheduled to go on AI after treatment can be recruited.)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217201


Contacts
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Contact: Laura Guttentag, MSW 212-659-5547 Laura.guttentag@mssm.edu

Locations
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United States, California
City of Hope Cancer Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Joanne Mortimer, MD    800-826-4673    JMortimer@coh.org   
Principal Investigator: Joanne Mortimer, MD         
United States, New Jersey
Hackensack University Medical Center Withdrawn
Hackensack, New Jersey, United States, 07601
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Laura Guttentag, MSW    212-659-5547    laura.guttentag@mssm.edu   
Principal Investigator: William H. Redd, Ph.D.         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Wendy Lichtenthal, PhD    212-639-7592      
Principal Investigator: Wendy Lichtenthal, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
City of Hope Medical Center
Investigators
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Principal Investigator: William H. Redd, Ph.D. Icahn School of Medicine at Mount Sinai

Additional Information:
Publications:
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Responsible Party: William H. Redd, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03217201    
Other Study ID Numbers: GCO 15-1783
1R01CA207446-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William H. Redd, Icahn School of Medicine at Mount Sinai:
Breast Cancer
Oncology
Circadian Rhythm
Light Therapy
Chemotherapy side effects
Additional relevant MeSH terms:
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Chronobiology Disorders
Fatigue
Signs and Symptoms
Nervous System Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors