Акупрессура аурикулярной точки для лечения нейропатии, вызванной химиотерапией
9 июля 2026 г. обновлено: Jennifer Kawi, The University of Texas Health Science Center, Houston
Предлагаемое рандомизированное контрольное исследование будет оценивать аурикулярную точечную акупрессуру (АТА) на вызванную химиотерапией невропатию (CIN), строго учитывая точечную специфичность и эффекты плацебо путем интеграции показателей самоотчета, психофизических показателей (QST), эндогенных биомаркеров (цитокинов) и нейропатии. - визуализация для исследования эффективности АПА и лежащего в ее основе механизма (механизмов).
Исследователи будут использовать рандомизированное контрольное исследование с тремя группами: (1) группа APA, (2) фиктивный контроль APA и (3) контроль обычного ухода. Приложение для смартфона для мгновенной экологической оценки (EMA) будет использоваться для мониторинга соблюдения АПА и регистрации мгновенной тяжести CIN и использования анальгетиков.
Обзор исследования
Статус
Завершенный
Подробное описание
Индуцированная химиотерапией невропатия (CIN) — боль, онемение или покалывание, распространяющиеся в руках и ногах, — вызывает стойкие симптомы, влияющие на чувствительность и равновесие у выживших после рака. До 50% выживших после рака продолжают страдать CIN через 6 лет после лечения. Было обнаружено, что дулоксетин, единственный препарат, рекомендованный Американским обществом клинической онкологии, превосходит плацебо, но улучшает CIN всего на 0,73 балла (шкала 0–10). Эффективного лечения CIN не установлено, за исключением физических упражнений, с величиной эффекта <0,508. Опиоиды облегчают боль в ЦИН, но их длительное использование настоятельно не рекомендуется из-за чрезмерного употребления опиоидов.
Исследователи предлагают протестировать аурикулярную точечную акупрессуру (APA) — инновационное и масштабируемое решение, разработанное на основе аурикулярной акупунктуры. АПА — это неинвазивное (безыгольное) и активное лечение пациентов с болью, тогда как иглоукалывание — это инвазивное (с использованием игл) и пассивное лечение (которое проводит лицензированный практикующий врач). В APA маленькие семена прикрепляются к определенным ушным точкам опытным врачом, и пациенты нажимают на семена, чтобы стимулировать ушные точки три раза в день, по три минуты каждый раз, в общей сложности девять минут в день. APA обеспечивает облегчение боли в течение 1-2 минут после стимуляции уха и поддерживает облегчение боли в течение одного месяца после 4-недельного вмешательства APA. APA популярен на Тайване, в Китае и Европе. Хотя его использование в США невелико, ограниченное количество клинических испытаний подтвердило эффективность АПА в лечении боли.
Тип исследования
Интервенционный
Регистрация (Действительный)
238
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21205
- Johns Hopkins University
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- The University of Texas Health Science Center at Houston
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Описание
Критерии включения:
- онкологические больные в возрасте ≥18 лет
- получали лекарство одной из следующих категорий: препараты на основе платины, алкалоиды барвинка, бортезомиб, эрибулин и/или таксаны
- завершили курс химиотерапии за три месяца или более до зачисления
- иметь CIN из-за нейротоксической химиотерапии рака или иметь ранее существовавшую периферическую невропатию другой этиологии, которая ухудшилась после химиотерапии
- имеют среднюю интенсивность боли, онемения или покалывания в конечностях на предыдущей неделе из-за CIN ≥ 4 по 11-балльной числовой шкале.
Критерий исключения:
- использование исследуемого агента для обезболивания одновременно или в течение последних 30 дней
- использование имплантируемой системы доставки лекарств, т.е. Медтроник СинхроМед®
- предшествующая блокада чревного сплетения или другое нейролитическое обезболивающее лечение
- другие выявленные причины болезненной парестезии, существовавшие до химиотерапии (например, радиационная или злокачественная плексопатия, поясничная или шейная радикулопатия)
- аллергия на латекс (ленты для АПА включают латекс).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Акупрессура аурикулярной точки (АПА)
Подразделение APA будет получать еженедельное индивидуальное лечение и приложение для смартфона с самостоятельным управлением с видео для понимания и применения APA.
Подразделение APA получит одно личное размещение семян и обучение для участника или его опекуна по размещению семян в точках ушей, а также одну встречу в масштабе через 1 неделю после первого визита для обучения участника и/или опекуна по посеву. размещение.
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Личное размещение семян и обучение участника или его опекуна размещению семян в точках ушей.
Сеанс Zoom для размещения семян и инструктажа по APA, который состоится после первоначального обучения APA и размещению семян (первоначальное обучение проводится либо лично, либо под руководством видео из приложения для смартфона).
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Экспериментальный: Акупрессура виртуальной аурикулярной точки (vAPA)
Подразделение vAPA будет самостоятельно вводить APA, размещая семена в соответствии с видеоинструкцией, которую можно найти в приложении для самостоятельного управления смартфоном для понимания и применения APA.
Участник и/или лицо, осуществляющее уход, будут следовать видеоинструкции по размещению семян и получат один сеанс масштабирования для коучинга APA через неделю после базового визита.
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Сеанс Zoom для размещения семян и инструктажа по APA, который состоится после первоначального обучения APA и размещению семян (первоначальное обучение проводится либо лично, либо под руководством видео из приложения для смартфона).
Самостоятельно администрируйте APA, помещая семена в соответствии с видеоинструкцией, которая находится в приложении для самостоятельного управления смартфоном для понимания и администрирования APA.
Участник и/или опекун будут следовать видеоинструкции по размещению семян.
Другие имена:
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Активный компаратор: Обычный контроль ухода
Подразделение обычного ухода продолжит оказывать обычный уход.
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Участники продолжат получать обычную помощь со стороны онколога.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Pain Severity as Assessed by the Brief Pain Inventory
Временное ограничение: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst pain severity.
The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
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Baseline, 1 month after baseline
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Numbness as Assessed by the Brief Pain Inventory
Временное ограничение: Baseline, 1 month after Baseline
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Brief Pain Inventory (BPI) assesses worst numbness.
The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
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Baseline, 1 month after Baseline
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Tingling as Assessed by the Brief Pain Inventory
Временное ограничение: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst Tingling.
The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
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Baseline, 1 month after baseline
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Stiffness as Assessed by the Brief Pain Inventory
Временное ограничение: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst stiffness.
The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
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Baseline, 1 month after baseline
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Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Временное ограничение: Baseline, 1 month after baseline
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Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Временное ограничение: Baseline, 1 month after baseline
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Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
Временное ограничение: Baseline, 1 month after Baseline
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The BPI-CIN Interference subscale will be used to measure physical function caused by CIN.
The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life.
Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes).
The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
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Baseline, 1 month after Baseline
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Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Временное ограничение: Baseline, 1 month after Baseline
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The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction
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Baseline, 1 month after Baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better physical function.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater fatigue.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater pain interference.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater depression severity.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater anxiety.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater sleep disturbance.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
Временное ограничение: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better and higher functioning social participation.
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Baseline, 1 month after baseline
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Upper Limb Function as Assessed by the Quick Dash Index
Временное ограничение: Baseline, 1 month after baseline
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The QuickDASH Index assesses upper limb disability and symptoms.
It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances.
The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
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Baseline, 1 month after baseline
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Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
Временное ограничение: Baseline, 1 month after Baseline
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The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer.
Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine).
The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
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Baseline, 1 month after Baseline
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Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Временное ограничение: Baseline, 1 month after Baseline
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Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain.
Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
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Baseline, 1 month after Baseline
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Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
Временное ограничение: Baseline, 1 month after Baseline
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The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline, 1 month after Baseline
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Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
Временное ограничение: Baseline, 1 month after Baseline
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Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS).
This instrument identifies the presence of up to 10 common chronic pain conditions.
The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
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Baseline, 1 month after Baseline
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Charlson Comorbidity Index
Временное ограничение: Baseline
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The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality.
The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
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Baseline
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Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
Временное ограничение: Baseline, 1 month after baseline
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Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life.
Each item is rated on a 0-10 scale.
The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
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Baseline, 1 month after baseline
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Number of Participants Reporting Opioid Use
Временное ограничение: Baseline, Day 28
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Baseline, Day 28
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Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
Временное ограничение: Baseline, Day 28
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Opioid use will be collected via EMA diary using a questionnaire.
Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid.
Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis.
Baseline was defined as the first day of opioid use recorded in the EMA diary.
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Baseline, Day 28
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
Временное ограничение: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb
Временное ограничение: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)
Временное ограничение: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation.
Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
A higher score means greater pain sensitivity and increased temporal summation.
MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
Временное ограничение: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds.
[ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
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Baseline, 1 month after Baseline
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Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging
Временное ограничение: Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline
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Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging
Временное ограничение: Baseline, 1 month after Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
|
Baseline, 1 month after Baseline
|
|
The Grooved Pegboard Test-Dominant Hand
Временное ограничение: Baseline, 1 month after baseline
|
The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with dominant hand.
Higher times indicate slower performance and reduced dexterity
|
Baseline, 1 month after baseline
|
|
The Grooved Pegboard Test-Non Dominant Hand
Временное ограничение: Baseline, 1 month after Baseline
|
The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with non-dominant hand.
Higher times indicate slower performance and reduced dexterity
|
Baseline, 1 month after Baseline
|
|
Interleukin-1 Alpha Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-1 Beta Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-2 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-4 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-6 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-8 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-10 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p40) (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p70)-(From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-13 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-17 Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interferon-gamma Level (From Plasma)
Временное ограничение: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Временное ограничение: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Временное ограничение: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Transforming Growth Factor-beta Level 1(From Plasma)
Временное ограничение: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Transforming Growth Factor-beta Level 1 (From Plasma)
Временное ограничение: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Calcitonin Gene-related Peptide Level(From Plasma)
Временное ограничение: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Monocyte Chemoattractant Protein-1 Level (From Plasma)
Временное ограничение: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Eotaxin Level (From Plasma)
Временное ограничение: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
C-reactive Protein Level (From Plasma)
Временное ограничение: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University
- Главный следователь: Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, The University of Texas Health Science Center, Houston
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
8 июля 2021 г.
Первичное завершение (Действительный)
30 мая 2025 г.
Завершение исследования (Действительный)
19 марта 2026 г.
Даты регистрации исследования
Первый отправленный
3 июня 2021 г.
Впервые представлено, что соответствует критериям контроля качества
3 июня 2021 г.
Первый опубликованный (Действительный)
9 июня 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HSC-SN-21-1085
- 1R01CA245054-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .