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NCT03217201 · ClinicalTrials.gov registry record · NA
Systematic Light Exposure for Fatigue in Breast Cancer Patients
A NA study of Fatigue and Cancer-related Problem/Condition, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 194
- Enrollment target
- 3
- Study locations
NCT03217201 is a NA study of Fatigue and Cancer-related Problem/Condition that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 194 participants, below the 216-participant average among 109 other Fatigue trials with a reported enrollment target (10% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT03217201, a NA study of Fatigue and Cancer-related Problem/Condition, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
- 3
- Study locations
Study 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 fa
Conditions Studied
Interventions
- DEVICE Light Glasses (Experimental)
- DEVICE Light Glasses (Comparison)
Study Locations (3)
New York
- Icahn School of Medicine at Mount Sinai - New York
- Memorial Sloan-Kettering Cancer Center - New York
California
- City of Hope Cancer Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2022-01-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03217201
The ClinicalTrials.gov registry entry for NCT03217201 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 216-participant average among 109 other Fatigue trials with a reported enrollment target (10% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Fatigue appearing as the primary indexed condition, and to 2 interventions - of which Light Glasses (Experimental) is the first listed.
NCT03217201 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, California.
Frequently Asked Questions
What is clinical trial NCT03217201 about?
NCT03217201 is a clinical study titled "Systematic Light Exposure for 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...
What is the current status of trial NCT03217201?
This trial is currently completed. It is a NA study. The enrollment target is 194 participants. The study started on 2018-01-25. Estimated completion is 2022-01-26.
What conditions does trial NCT03217201 study?
This clinical trial studies the following conditions: Fatigue, Cancer-related Problem/Condition, Circadian Rhythm Disorders.
What interventions are being tested in trial NCT03217201?
The interventions under investigation include: Light Glasses (Experimental) (DEVICE), Light Glasses (Comparison) (DEVICE).
Who is sponsoring clinical trial NCT03217201?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03217201 being conducted?
This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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