The Ambient Light Multiple Myeloma Study

Mount Sinai Health System

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Device: Circadian Effective Lighting; Device: Circadian Ineffective Lightning (CIL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05737732

STUDY-21-01146

Details and patient eligibility

About

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.

Full description

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 light is a strong synchronizer of circadian rhythms, the proposed multi-site randomized controlled trial (RCT) will investigate whether lighting designed to deliver circadian effective light that promotes circadian alignment, will: 1) promote higher nighttime melatonin levels and better nighttime sleep, 2) reduce pro-inflammatory cytokines, 3) lower rates of neutropenic fever and 4) improve symptom burden in cancer patients undergoing Autologous Stem Cell Transplant.

Hospital rooms for patients undergoing inpatient Autologous Stem Cell Transplant at the Mount Sinai Medical Center (MSMC) and at the Memorial Sloan Kettering Cancer Center (MSKCC)) will be retrofitted to install 1 of 2 lighting interventions, either circadian-effective (intervention) and circadian-ineffective (comparison) ambient light that may improve sleep.

1-2 weeks and no more than 2 months prior to transplant, participants will be given an Actiwatch, Daysimeter (personal light meter), sleep logs, questionnaires, and a urine collection kit to assess melatonin. One blood sample for cytokine analyses will be collected during one of the hospital visits prior to transplant. Blood draws are always done in the morning and always at a similar time for the same individual. The same outcomes (questionnaires, Actiwatch, Daysimeter, urine samples, blood samples) will be collected during transplant period and once, four weeks after engraftment.

Enrollment: 200 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Circadian Effective Lighting (CEL)

Active Comparator group

Description:

The CEL will be performed in hospital sites over a 2-month period.

Treatment:

Device: Circadian Effective Lighting

Circadian Ineffective Lighting (CIL)

Sham Comparator group

Description:

The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

Treatment:

Device: Circadian Ineffective Lightning (CIL)