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NCT03119363 · ClinicalTrials.gov registry record · NA
Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 194
- Enrollment target
NCT03119363: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03119363 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 194 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03119363, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
Study Summary
Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from three medical centers. The light will be administered by a small, personal light glasses daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. 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.
Primary Outcome
Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale. 13-item scale, each item 0=not at all to 4=very much, with higher score indicating more fatigue
Interventions
- DEVICE AYO light glasses (Experimental)
- DEVICE AYO light glasses (Comparator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2022-04-01 |
| Phase | NA |
What the finished NCT03119363 record still lists
NCT03119363 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which AYO light glasses (Experimental) is the first listed.
NCT03119363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03119363 about?
NCT03119363 is a clinical study titled "Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)". Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological...
What is the current status of trial NCT03119363?
This trial is currently completed. It is a NA study. The enrollment target is 194 participants. The study started on 2015-09-01. Estimated completion is 2022-04-01.
What interventions are being tested in trial NCT03119363?
The interventions under investigation include: AYO light glasses (Experimental) (DEVICE), AYO light glasses (Comparator) (DEVICE).
Who is sponsoring clinical trial NCT03119363?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03119363's enrollment target sits among peer trials
194 568th of 2000 higher than 1,432 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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