화학 요법으로 유발된 신경병증을 관리하기 위한 귀점 지압
2026년 7월 9일 업데이트: Jennifer Kawi, The University of Texas Health Science Center, Houston
제안된 무작위 대조 시험은 화학 요법 유발 신경병증(CIN)에 대한 귀점 지압(APA)을 평가하고, 자가 보고 측정, 정신물리학적 측정(QST), 내인성 바이오마커(사이토카인) 및 신경 -APA의 효능 및 기본 메커니즘(들)을 조사하기 위한 이미징.
조사관은 무작위 통제 시험, 3개 그룹 디자인: (1) APA 그룹, (2) 가짜 APA 통제 및 (3) 일반적인 치료 통제를 사용할 것입니다. 생태 순간 평가(EMA)용 스마트폰 애플리케이션을 사용하여 APA 준수를 모니터링하고 순간적인 CIN 중증도 및 진통제 사용을 캡처합니다.
연구 개요
상태
완전한
상세 설명
화학요법 유발 신경병증(CIN) - 손과 발에 분포하는 통증, 저림 또는 저림은 암 생존자의 감각과 균형에 영향을 미치는 지속적인 증상을 일으킵니다. 암 생존자의 최대 50%가 치료 후 6년이 지난 후에도 여전히 CIN을 앓고 있습니다. 미국임상종양학회에서 유일하게 추천한 약물인 둘록세틴은 위약보다 우월한 것으로 나타났지만 CIN은 0.73점(0-10 척도)만 향상되었다. CIN에 대한 효과 크기가 0.508 미만인 운동을 제외하고는 효과적인 치료법이 확립되지 않았습니다. 아편유사제는 CIN 통증을 완화하지만 아편유사제 남용으로 인해 장기간 사용을 강력히 권장하지 않습니다.
연구자들은 귀 침술에서 개발된 혁신적이고 확장 가능한 솔루션인 귀 점 지압(APA)을 테스트할 것을 제안합니다. APA는 통증이 있는 환자를 위한 비침습적(바늘 없는) 능동적 치료법인 반면 침술은 침습적(바늘 사용) 수동적 치료법(면허가 있는 개업의가 시행)입니다. APA에서는 숙련된 제공자가 작은 씨앗을 특정 귀점에 테이프로 붙이고 환자는 씨앗을 눌러 귀점을 하루에 세 번, 한 번에 3분, 하루 총 9분 동안 자극합니다. APA는 귀 자극 후 1-2분 이내에 통증 완화를 제공하고 4주 APA 개입 후 한 달 동안 통증 완화를 지속합니다. APA는 대만, 중국 및 유럽에서 인기가 있습니다. 미국에서는 사용이 드물지만 제한된 수의 임상 시험에서 통증 관리에 APA를 지원했습니다.
연구 유형
중재적
등록 (실제)
238
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins University
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 18세 이상 암 환자
- 백금 기반, 빈카 알칼로이드, 보르테조밉, 에리불린 및/또는 탁산 범주 중 하나의 약물을 투여 받았습니다.
- 등록 전 3개월 이상 동안 화학 요법 과정을 완료했습니다.
- 암에 대한 신경 독성 화학 요법을 받기 때문에 CIN이 있거나 화학 요법 후에 악화된 다른 병인의 말초 신경 병증이 이미 존재합니다.
- 지난 주에 11점 수치 척도에서 CIN ≥ 4로 인해 사지의 통증, 무감각 또는 따끔거림의 평균 강도 중 하나가 있습니다.
제외 기준:
- 통증 조절을 위해 동시에 또는 지난 30일 이내에 연구용 제제 사용
- 이식형 약물 전달 시스템의 사용, 예. 메드트로닉 SynchroMed®
- 이전 복강 신경총 차단 또는 기타 신경 통증 조절 치료
- 화학 요법 이전에 존재하는 고통스러운 감각 이상증의 다른 확인된 원인(예: 방사선 또는 악성 신경총병증, 요추 또는 경추 신경근병증)
- 라텍스에 대한 알레르기(APA용 테이프에는 라텍스가 포함됨).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 귀점 지압(APA)
APA 암은 매주 대면 치료를 받고 APA를 이해하고 관리하기 위한 비디오가 포함된 셀프 가이드 스마트폰 애플리케이션을 받게 됩니다.
APA 부서는 1회의 직접 종자 배치와 참가자 또는 간병인이 이어 포인트에 종자를 배치하는 교육을 받을 뿐만 아니라 참가자 및/또는 간병인의 종자 코치를 처음 방문한 후 1주일 후에 1회의 줌 미팅을 받게 됩니다. 놓기.
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직접 종자 배치 및 참가자 또는 간병인이 귀점에 종자를 배치하도록 교육합니다.
종자 배치 및 APA 코칭을 위한 줌 세션은 초기 APA 및 종자 배치 교육 후에 진행됩니다(초기 교육은 직접 또는 스마트폰 앱 비디오를 통해 안내됩니다).
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실험적: 가상 귓바퀴점 지압(vAPA)
VAPA 암은 APA를 이해하고 관리하기 위해 자가 유도 스마트폰 애플리케이션에 있는 비디오 지침에 따라 씨앗을 배치하여 APA를 자가 관리합니다.
참가자 및/또는 간병인은 종자 배치에 대한 비디오 지침을 따르고 기본 방문 후 1주일 후에 APA 코칭을 위한 줌 세션을 1회 받게 됩니다.
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종자 배치 및 APA 코칭을 위한 줌 세션은 초기 APA 및 종자 배치 교육 후에 진행됩니다(초기 교육은 직접 또는 스마트폰 앱 비디오를 통해 안내됩니다).
APA를 이해하고 관리하기 위해 자가 유도 스마트폰 애플리케이션에 있는 비디오 지침에 따라 씨앗을 배치하여 APA를 자가 관리합니다.
참가자 및/또는 간병인은 종자 배치에 대한 비디오 지침을 따릅니다.
다른 이름들:
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활성 비교기: 평소 케어 컨트롤
일반 케어(Usual Care) 부문은 평소의 케어를 계속할 것입니다.
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참가자는 종양 전문의의 일반적인 치료를 계속 받게 됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Severity as Assessed by the Brief Pain Inventory
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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.
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Baseline, 1 month after Baseline
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The Grooved Pegboard Test-Dominant Hand
기간: Baseline, 1 month after baseline
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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
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Baseline, 1 month after baseline
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The Grooved Pegboard Test-Non Dominant Hand
기간: Baseline, 1 month after Baseline
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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
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Baseline, 1 month after Baseline
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Interleukin-1 Alpha Level (From Plasma)
기간: Baseline, 1 month after Baseline
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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.
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Baseline, 1 month after Baseline
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Interleukin-1 Beta Level (From Plasma)
기간: Baseline, 1 month after Baseline
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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.
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Baseline, 1 month after Baseline
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Interleukin-2 Level (From Plasma)
기간: Baseline, 1 month after Baseline
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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.
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Baseline, 1 month after Baseline
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Interleukin-4 Level (From Plasma)
기간: Baseline, 1 month after Baseline
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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.
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Baseline, 1 month after Baseline
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Interleukin-6 Level (From Plasma)
기간: Baseline, 1 month after Baseline
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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.
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Baseline, 1 month after Baseline
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Interleukin-8 Level (From Plasma)
기간: 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.
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Baseline, 1 month after Baseline
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Interleukin-10 Level (From Plasma)
기간: 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.
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Baseline, 1 month after Baseline
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Interleukin-12 Level (p40) (From Plasma)
기간: 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.
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Baseline, 1 month after Baseline
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Interleukin-12 Level (p70)-(From Plasma)
기간: 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.
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Baseline, 1 month after Baseline
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Interleukin-13 Level (From Plasma)
기간: 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
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|
Interleukin-17 Level (From Plasma)
기간: 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
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|
Interferon-gamma Level (From Plasma)
기간: 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.
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Baseline, 1 month after Baseline
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Tumor Necrosis Factor-alpha Level (From Plasma)
기간: 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)
기간: 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
|
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Transforming Growth Factor-beta Level 1(From Plasma)
기간: 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)
기간: 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)
기간: 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
|
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Monocyte Chemoattractant Protein-1 Level (From Plasma)
기간: 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
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Eotaxin Level (From Plasma)
기간: 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)
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University
- 수석 연구원: Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, The University of Texas Health Science Center, Houston
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 주요 날짜
연구 시작 (실제)
2021년 7월 8일
기본 완료 (실제)
2025년 5월 30일
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2021년 6월 3일
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2021년 6월 3일
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2026년 8월 4일
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추가 정보
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키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HSC-SN-21-1085
- 1R01CA245054-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
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아니요
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