Cancer-related Problem/ConditionNCT03217201
Systematic Light Exposure for Fatigue in Breast Cancer Patients
A study testing Light Glasses (Experimental) and Light Glasses (Comparison) in people with Cancer-related Problem/Condition and Fatigue, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer-related Problem/Condition, Fatigue, Circadian Rhythm Disorders
- What is being tested?
- Light Glasses (Experimental) and Light Glasses (Comparison)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2018to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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))
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope Cancer Center
Duarte, California, 91010
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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 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.
- Being tested
- Light Glasses (Experimental), Light Glasses (Comparison)
- Keywords
- Breast Cancer, Oncology, Circadian Rhythm, Light Therapy, Chemotherapy side effects
- Medical subject headings
- Fatigue, Chronobiology Disorders, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Glasses (Experimental)Device
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.
Light Glasses (Comparison)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant, Experimental Light | Experimental | 30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment. Receives: Device: Light Glasses (Experimental) |
| Adjuvant, Comparison Light | Active comparator | 30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment. Receives: Device: Light Glasses (Comparison) |
| Neo-Adjuvant, Experimental Light | Experimental | 30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment. Receives: Device: Light Glasses (Experimental) |
| Neo-Adjuvant, Comparison Light | Active comparator | 30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment. Receives: Device: Light Glasses (Comparison) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (4)
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.
Measured: up to 6 months
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).
Measured: up to 6 months
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start25 Jan 2018
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified by adjuvant and neoadjuvant chemotherapy treatments, then randomly assigned to one of two light treatment conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), City of Hope Medical Center
- Responsible party
- Principal investigator, William H. Redd, Icahn School of Medicine at Mount Sinai
- Investigators
- William H. Redd, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217201
- Sponsor's protocol ID
- GCO 15-1783
- Other IDs
- 1R01CA207446-01A1
- Status last verified
- Aug 2023
- First submitted
- 11 Jul 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23404818Minton 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.
PubMed 18064565
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03217201
- Acronym / sponsor ID
- GCO 15-1783
- Keywords
- Breast Cancer, Oncology, Circadian Rhythm, Light Therapy, Chemotherapy side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), City of Hope Medical Center
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Stratified by adjuvant and neoadjuvant chemotherapy treatments, then randomly assigned to one of two light treatment conditions.
| Arm | Type | Receives |
|---|---|---|
| Adjuvant, Experimental Light | Experimental | Device: Light Glasses (Experimental)30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment. |
| Adjuvant, Comparison Light | Active comparator | Device: Light Glasses (Comparison)30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment. |
| Neo-Adjuvant, Experimental Light | Experimental | Device: Light Glasses (Experimental)30 minutes of experimental systematic light exposure daily for duration of chemotherapy treatment. |
| Neo-Adjuvant, Comparison Light | Active comparator | Device: Light Glasses (Comparison)30 minutes of comparison systematic light exposure daily for duration of chemotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adjuvant, Experimental Light, Neo-Adjuvant, Experimental Light |
| 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. | Device | Adjuvant, Comparison Light, Neo-Adjuvant, Comparison Light |
Primary outcome
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.
4 secondary outcomes
The Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: up to 6 months
The Pittsburgh Sleep Quality Index
Time frame: up to 6 months
Chronotype (MEQ)
Time frame: up to 6 months
Credibility/Expectancy Questionnaire
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 23404818Rotonda 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.
- Background: PubMed 18064565Minton 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.
- Breast CancerLink provided by the sponsor.
- FatigueLink provided by the sponsor.
- Cancer-Related FatigueLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H. Redd, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Glasses (Experimental) and Light Glasses (Comparison) in people with Cancer-related Problem/Condition and Fatigue, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-Fatigue Scale (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217201, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.