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임상시험 NCT06144164은(는) 림프부종, 팔 림프부종, 상완 림프부종, 유방암, 유방암, 여성 유방암에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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메모리얼 슬론 케터링 암센터A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06144164은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 림프부종, 팔 림프부종, 상완 림프부종, 유방암, 유방암, 여성 유방암에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2023년 11월 16일에 시작되어 285명의 참여자를 모집하고 있습니다. 메모리얼 슬론 케터링 암센터이(가) 진행하며, 2030년 3월 16일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 7일에 갱신되었습니다.
간단한 개요
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
공식 제목
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
질환/상태
림프부종팔 림프부종상완 림프부종유방암유방암여성 유방암기타 연구 식별자
- 23-303
NCT 번호
실제 연구 시작일
2023-11-16
최신 업데이트 게시
2025-11-07
예상 연구 완료일
2030-03-16
계획된 등록 인원
285
연구종류
중재연구
단계/상
3상
상태
모집중
키워드
immediate lymphatic reconstruction
axillary lymph node dissection
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast cancer
breast carcinoma
female breast cancer
Memorial Sloan Kettering Cancer Center
23-303
axillary lymph node dissection
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast cancer
breast carcinoma
female breast cancer
Memorial Sloan Kettering Cancer Center
23-303
주요 목적
예방
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Participants with Breast Cancer Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection. | Immediate Lymphatic Reconstruction Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection Volumetric ARM Measurements Volumetric arm measurements will occur at each in-person postoperative visit time points. Lymphatic Massage Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed Range of Motion Exercises Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed Compression Garment Use Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The difference between the baseline and postoperative arm volume measurement | The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema | Up to 24 months |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
- Male sex
- Does not speak English
- Does not fit into study garment
- Axillary recurrence
- History of ALND
- Requirement of bilateral ALND for the treatment of breast cancer
- Treatment with SLNB only
- Known anaphylactic allergy to ICG dye used in ILR
- Impaired decision-making capacity
메모리얼 슬론 케터링 암센터737개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Michelle Coriddi, MD, 646-608-8042, [email protected]
연락처: Babak Mahrara, MD, 646-608-8085, [email protected]
7 1개국에 임상시험 장소
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States
Michelle Coriddi, MD, 연락처, 646-608-8042
모집중