NCT03217201

Systematic Light Exposure for Fatigue in Breast Cancer Patients

Completed NA Last updated 23 August 2023

What this trial tests

NA trial testing Light Glasses (Experimental) in Cancer-related Problem/Condition in 194 participants. Completed in 26 January 2022.

Timeline

25 January 2018

Primary endpoint
26 January 2022

26 January 2022

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	194
Start date	25 January 2018
Primary completion	26 January 2022
Estimated completion	26 January 2022
Sites	3 locations across United States

Drugs / interventions tested

• Light Glasses (Experimental)
• Light Glasses (Comparison)

Conditions studied

• Cancer-related Problem/Condition — all drugs for Cancer-related Problem/Condition →
• Fatigue — all drugs for Fatigue →
• Circadian Rhythm Disorders — all drugs for Circadian Rhythm Disorders →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, female only, with Cancer-related Problem/Condition or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integration of circadian rhythms and immunotherapy for enhanced precision in brain cancer treatment.
   Quist M, van Os M, van Laake LW, Bovenschen N, et al · · 2024 · cited 11× · PMID 39413708 · DOI 10.1016/j.ebiom.2024.105395
2. Circadian clocks and adaptive immune function: from mechanisms to therapeutic applications.
   Szredzka A, Chwastowicz A, Pergoł J, Matryba P. · · 2025 · PMID 41415271 · DOI 10.3389/fimmu.2025.1697854