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Systematic Light Exposure for Fatigue in Breast Cancer Patients

Primary Purpose

Cancer-related Problem/Condition, Fatigue, Circadian Rhythm Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light Glasses (Experimental)
Light Glasses (Comparison)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer-related Problem/Condition focused on measuring Breast Cancer, Oncology, Circadian Rhythm, Light Therapy, Chemotherapy side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.
  • 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.

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
  • 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

Sites / Locations

  • City of Hope Cancer Center
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Adjuvant, Experimental Light

Adjuvant, Comparison Light

Neo-Adjuvant, Experimental Light

Neo-Adjuvant, Comparison Light

Arm Description

30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.

30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.

30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.

30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Center for Epidemiological Studies Depression Scale (CES-D)
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.
The Pittsburgh Sleep Quality Index
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).
Chronotype (MEQ)
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.
Credibility/Expectancy Questionnaire
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.

Full Information

First Posted
July 11, 2017
Last Updated
August 22, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03217201
Brief Title
Systematic Light Exposure for Fatigue in Breast Cancer Patients
Official Title
Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), City of Hope Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition, Fatigue, Circadian Rhythm Disorders
Keywords
Breast Cancer, Oncology, Circadian Rhythm, Light Therapy, Chemotherapy side effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratified by adjuvant and neoadjuvant chemotherapy treatments, then randomly assigned to one of two light treatment conditions.
Masking
Participant
Masking Description
The participant does not know his or her study condition.
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant, Experimental Light
Arm Type
Experimental
Arm Description
30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Arm Title
Adjuvant, Comparison Light
Arm Type
Active Comparator
Arm Description
30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Arm Title
Neo-Adjuvant, Experimental Light
Arm Type
Experimental
Arm Description
30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment.
Arm Title
Neo-Adjuvant, Comparison Light
Arm Type
Active Comparator
Arm Description
30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment.
Intervention Type
Device
Intervention Name(s)
Light Glasses (Experimental)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Light Glasses (Comparison)
Intervention Description
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 Measure Information:
Title
FACIT-Fatigue Scale
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
The Center for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
up to 6 months
Title
The Pittsburgh Sleep Quality Index
Description
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).
Time Frame
up to 6 months
Title
Chronotype (MEQ)
Description
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.
Time Frame
up to 6 months
Title
Credibility/Expectancy Questionnaire
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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. 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H. Redd, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23404818
Citation
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.
Results Reference
background
PubMed Identifier
18064565
Citation
Minton 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.
Results Reference
background
Links:
URL
https://www.cancer.org/cancer/breast-cancer.html
Description
Breast Cancer
URL
https://medlineplus.gov/fatigue.html
Description
Fatigue
URL
https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/what-is-cancer-related-fatigue.html
Description
Cancer-Related Fatigue

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Systematic Light Exposure for Fatigue in Breast Cancer Patients

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