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Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation


Description

The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, Neutropenic Fever and Symptom Burden among Multiple Myeloma Patients undergoing Autologous Stem Cell Transplantation. To achieve this aim, 200 multiple myeloma patients will receive one of two different light-treatments that are designed to promote circadian rhythm alignment. While receiving these light treatments, participants' sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels and symptoms will be assessed over a 2-month period.Individuals undergoing Autologous Stem Cell Transplant (ASCT) experience major transplant-related complications including elevated symptom burden, high rates of neutropenic fever, and increases in inflammatory cytokines. These transplant-related complications are augmented by circadian rhythms disruption (CRD), which leads to misalignment between melatonin levels and sleep times. Since

Trial Eligibility

Inclusion Criteria: * Multiple Myeloma diagnosis * Scheduled to undergo their first Autologous Stem Cell Transplant procedure. * 21years or older * Able to provide informed consent. * English-language proficient Exclusion Criteria: * Previous Autologous Stem Cell Transplant procedure * Pregnancy * Eye diseases which limit the ability of light to be processed * Secondary cancer diagnosis within the last 5 years * Severe sleep disorders * History of bipolar disorder or manic episodes * Severe psychological impairment * Previous use of light therapy * Active infection including COVID-19 infection

Study Info

Organization

Icahn School of Medicine at Mount Sinai


Primary Outcome

Changes in Urinary Melatonin


Outcome Timeframe Baseline visit and 3 days after the Autologous Stem Cell Transplant

NCTID NCT05737732

Phases NA

Primary Purpose TREATMENT

Start Date 2023-02-13

Completion Date 2027-06-30

Enrollment Target 200

Interventions

DEVICE Circadian Effective Lighting

DEVICE Circadian Ineffective Lightning (CIL)

Locations Recruiting

Icahn Schoool of Medicine at Mount Sinai

United States, New York, New York


Memorial Sloan Kettering Cancer Center

United States, New York, New York


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