The Ambient Light Multiple Myeloma Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Circadian Effective Lighting, Circadian Ineffective Lightning (CIL).
- Кому может быть актуально
- Состояния в реестре: Multiple Myeloma. Базовые параметры: от 21 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство Circadian 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. - Устройство Circadian 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.
Первичные конечные точки
- Changes in Urinary Melatonin [Срок оценки: Baseline visit and 3 days after the Autologous Stem Cell Transplant]
Вторичные конечные точки (12)
- Sleep Efficiency using Actigraphy at 7 days post-transplant [Срок оценки: at 7 days post-transplant]
- Sleep Efficiency using Actigraphy at 3 days after engraftment [Срок оценки: at 3 days after engraftment]
- Sleep Efficiency using Actigraphy at 4 weeks after engraftment [Срок оценки: at 4 weeks after engraftment]
- Inflammatory cytokine CRP levels at Baseline [Срок оценки: At baseline, or during the hospital visit prior to transplant]
- Inflammatory cytokine CRP levels at 7 days following transplant [Срок оценки: at 7 days following transplant]
- Inflammatory cytokine CRP levels at 3 days following engraftment [Срок оценки: at 3 days following engraftment]
- Inflammatory cytokine CRP levels at 4 weeks following engraftment [Срок оценки: at 4 weeks following engraftment]
- Number of Neutropenic Fevers at 7 days post-transplant [Срок оценки: at 7 days post-transplant]
- Number of Neutropenic Fevers at 3 days after engraftment [Срок оценки: at 3 days after engraftment]
- Number of Neutropenic Fevers at 4 weeks after engraftment [Срок оценки: at 4 weeks after engraftment]
- Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant [Срок оценки: at 7 days post-transplant]
- Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment [Срок оценки: at 3 days after engraftment]
Критерии участия
Критерии включения
- Multiple Myeloma diagnosis
- Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
- 21years or older
- Able to provide informed consent.
- English-language proficient
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Icahn Schoool of Medicine at Mount Sinai — New York
- Memorial Sloan Kettering Cancer Center — New York
Идентификаторы
NCT: NCT05737732 · STUDY-21-01146