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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 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 194 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03119363
The ClinicalTrials.gov registry entry for NCT03119363 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. 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 0 conditions, and to 2 interventions - of which AYO light glasses (Experimental) is the first listed.
NCT03119363 reports 0 study locations.
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.
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