Clinical trial NCT05737732: The Ambient Light Multiple Myeloma Study
Official title: Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Urinary Melatonin
timeFrame: Baseline visit and 3 days after the Autologous Stem Cell Transplant
Secondary outcomes:
measure: Sleep Efficiency using Actigraphy at 7 days post-transplant
timeFrame: at 7 days post-transplant
measure: Sleep Efficiency using Actigraphy at 3 days after engraftment
timeFrame: at 3 days after engraftment
measure: Sleep Efficiency using Actigraphy at 4 weeks after engraftment
timeFrame: at 4 weeks after engraftment
measure: Inflammatory cytokine CRP levels at Baseline
timeFrame: At baseline, or during the hospital visit prior to transplant
measure: Inflammatory cytokine CRP levels at 7 days following transplant
timeFrame: at 7 days following transplant
measure: Inflammatory cytokine CRP levels at 3 days following engraftment
timeFrame: at 3 days following engraftment
measure: Inflammatory cytokine CRP levels at 4 weeks following engraftment
timeFrame: at 4 weeks following engraftment
measure: Number of Neutropenic Fevers at 7 days post-transplant
timeFrame: at 7 days post-transplant
measure: Number of Neutropenic Fevers at 3 days after engraftment
timeFrame: at 3 days after engraftment
measure: Number of Neutropenic Fevers at 4 weeks after engraftment
timeFrame: at 4 weeks after engraftment
measure: Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant
timeFrame: at 7 days post-transplant
measure: Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment
timeFrame: at 3 days after engraftment
measure: Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment
timeFrame: at 4 weeks after engraftment
measure: MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline
timeFrame: At baseline, or during the hospital visit prior to transplant
measure: MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant
timeFrame: at 7 days following transplant
measure: MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment
timeFrame: at 3 days following engraftment
measure: MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment
timeFrame: at 4 weeks following engraftment
measure: Perceived Stress Scale Score at Baseline
timeFrame: At baseline, or during the hospital visit prior to transplant
measure: Perceived Stress Scale Score at 7 days post-transplant
timeFrame: at 7 days post-transplant
measure: Perceived Stress Scale Score at 3 days following engraftment
timeFrame: at 3 days following engraftment
measure: Perceived Stress Scale Score at 4 weeks following engraftment
timeFrame: at 4 weeks following engraftment
measure: Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline
timeFrame: At baseline, or during the hospital visit prior to transplant
measure: Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 7 days post-engraftment
timeFrame: at 7 days following transplant
measure: Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment
timeFrame: at 3 days following engraftment
measure: Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment
timeFrame: at 4 weeks following engraftment
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline
timeFrame: At baseline, or during the hospital visit prior to transplant
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant
timeFrame: at 7 days following transplant
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment
timeFrame: at 3 days following engraftment
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment
timeFrame: at 4 weeks following engraftment
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn Schoool of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: