Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
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.
Arms & interventions
- DeviceCircadian Effective Lighting
Participants will receive lighting with a spectrum of 300K, 500 lux to the eye level between 7:00am and 10:00am in the morning, and hospital lighting (\<100lux) during the afternoon between 10:00am and 6:00pm. In the evening this group of participants will receive lighting with a spectrum of 3000K, \<50lux at eye light level between 6:00PM and bedtime.
- DeviceCircadian Ineffective Lightning (CIL)
Participants will receive lower lighting levels in the morning (lighting with A spectrum of 300k, \<50lux to the eye level between 7:00am and 10:00am) and the same lighting levels throughout the rest of the day.
Outcome measures
Primary
Changes in Urinary Melatonin
Participants will be given vials for collection and detailed instructions to void their bladders on AM rising and any prior nighttime voids starting 2 h prior to their normal bedtimes, at which time they will be asked to dim the lights down to a minimum and avoid using their self-luminous displays. Participants (and nurses) will collect each void during that overnight in a separate vial and to record the times of each voiding. Urinary melatonin-sulfate (6 sulfatoxymelatonin, aMT6s) measurements will be assayed using a commercially available ELISA kit (IBL International, Hamburg, Germany).
Time frame: Baseline visit and 3 days after the Autologous Stem Cell Transplant
Secondary
Sleep Efficiency using Actigraphy at 7 days post-transplant
Time frame: at 7 days post-transplant
Sleep Efficiency using Actigraphy at 3 days after engraftment
Time frame: at 3 days after engraftment
Sleep Efficiency using Actigraphy at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
Inflammatory cytokine CRP levels at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Inflammatory cytokine CRP levels at 7 days following transplant
Time frame: at 7 days following transplant
Inflammatory cytokine CRP levels at 3 days following engraftment
Time frame: at 3 days following engraftment
Inflammatory cytokine CRP levels at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Number of Neutropenic Fevers at 7 days post-transplant
Time frame: at 7 days post-transplant
Number of Neutropenic Fevers at 3 days after engraftment
Time frame: at 3 days after engraftment
Number of Neutropenic Fevers at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant
Time frame: at 7 days post-transplant
Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment
Time frame: at 3 days after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant
Time frame: at 7 days following transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment
Time frame: at 3 days following engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Perceived Stress Scale Score at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Perceived Stress Scale Score at 7 days post-transplant
Time frame: at 7 days post-transplant
Perceived Stress Scale Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Perceived Stress Scale Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 7 days post-engraftment
Time frame: at 7 days following transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant
Time frame: at 7 days following transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Eligibility criteria
Study locations (2)
Icahn Schoool of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065