Systematic Light Exposure for Fatigue in Breast Cancer Patients

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT03217201

Collaborator

Memorial Sloan Kettering Cancer Center (Other), National Cancer Institute (NCI) (NIH), City of Hope Medical Center (Other)

248

Enrollment

Locations

Arms

51.1

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer-related Problem/Condition Fatigue Circadian Rhythm Disorders	Device: Light Glasses (Experimental) Device: Light Glasses (Comparison)	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Jan 25, 2018

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

FACIT-Fatigue Scale [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Cancer Center	Duarte	California	United States	91010
2	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
3	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
4	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065