Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Changes in Urinary Melatonin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Myeloma diagnosis
- •Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
- •21years or older
- •Able to provide informed consent.
- •English-language proficient
排除标准
- •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
研究组 & 干预措施
Circadian Effective Lighting (CEL)
The CEL will be performed in hospital sites over a 2-month period.
干预措施: Circadian Effective Lighting (Device)
Circadian Ineffective Lighting (CIL)
The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.
干预措施: Circadian Ineffective Lightning (CIL) (Device)
结局指标
主要结局
Changes in Urinary Melatonin
时间窗: Baseline visit and 3 days after the Autologous Stem Cell Transplant
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).
次要结局
- Sleep Efficiency using Actigraphy at 4 weeks after engraftment(at 4 weeks after engraftment)
- Sleep Efficiency using Actigraphy at 7 days post-transplant(at 7 days post-transplant)
- Sleep Efficiency using Actigraphy at 3 days after engraftment(at 3 days after engraftment)
- Inflammatory cytokine CRP levels at Baseline(At baseline, or during the hospital visit prior to transplant)
- Inflammatory cytokine CRP levels at 4 weeks following engraftment(at 4 weeks following engraftment)
- Number of Neutropenic Fevers at 7 days post-transplant(at 7 days post-transplant)
- Perceived Stress Scale Score at 7 days post-transplant(at 7 days post-transplant)
- Inflammatory cytokine CRP levels at 7 days following transplant(at 7 days following transplant)
- Inflammatory cytokine CRP levels at 3 days following engraftment(at 3 days following engraftment)
- Number of Neutropenic Fevers at 3 days after engraftment(at 3 days after engraftment)
- Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment(at 4 weeks after engraftment)
- Number of Neutropenic Fevers at 4 weeks after engraftment(at 4 weeks after engraftment)
- Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant(at 7 days post-transplant)
- Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment(at 3 days after engraftment)
- MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline(At baseline, or during the hospital visit prior to transplant)
- MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant(at 7 days following transplant)
- MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment(at 3 days following engraftment)
- MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment(at 4 weeks following engraftment)
- Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline(At baseline, or during the hospital visit prior to transplant)
- Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment(at 3 days following engraftment)
- Perceived Stress Scale Score at Baseline(At baseline, or during the hospital visit prior to transplant)
- Perceived Stress Scale Score at 3 days following engraftment(at 3 days following engraftment)
- Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 7 days post-engraftment(at 7 days following transplant)
- Perceived Stress Scale Score at 4 weeks following engraftment(at 4 weeks following engraftment)
- Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment(at 4 weeks following engraftment)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline(At baseline, or during the hospital visit prior to transplant)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment(at 3 days following engraftment)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant(at 7 days following transplant)
- Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment(at 4 weeks following engraftment)
研究者
Mariana Figueiro
Professor, Director of Light and Health Research Center at Mount Sinai
Icahn School of Medicine at Mount Sinai