- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07638774
The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.
Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xichun Hu, MD,Phd
- 전화번호: 13816110335
- 이메일: xchu2009@hotmail.com
연구 연락처 백업
- 이름: Jian Zhang, MD,Phd
- 전화번호: 18017312991
- 이메일: zhangjian1001@csco.ac.cn
연구 장소
-
-
-
Shanghai, 중국
- 모병
- Fudan University Shanghai Cancer Center
-
연락하다:
- Jian Zhang, PHD
- 전화번호: 021-64175590
- 이메일: syner2000@163.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female ,18-75 years;
- Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;
- The participants is going to receive UTD1 based regimen at least 2 cycles;
- The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;
- ECOG score ≤1;
Adequate organ and bone marrow function defined as follows within 7 days before enrollment:
Absolute Neutrophil Count (ANC) ≥1,500/mm 3 (1.5 ×10 9/L), white blood cell count (WBC) ≥3.5×10 9/L, platelets ≥75,000/mm 3 (75×10 9/L), hemoglobin ≥9 g/dL (90 g/L), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.
Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.
- Expected survival time ≥12 weeks;
- No history of serious heart, lung, liver, kidney and other important organ diseases;
- Signed informed consent;
- Good compliance to the protocol;
- Women of childbearing age must already be using reliable contraception, a pregnancy test (blood or urine) is performed within 14 days before enrollment and the result was negative (if positive, pregnancy must be ruled out by ultrasound), and willing to use an appropriate methods of contraception during the trial and for 8 weeks after completion of the trial.
Exclusion Criteria:
- Previous treatment of UTD1;
- Severe uncontrolled infection.
- Patients with leptomeningeal metastases, symptomatic brain metastases, spinal cord compression, or brain or leptomeningeal disease detected on imaging at screening (patients who had completed local brain therapy 21 days before treatment and had stable symptoms and no cerebral hemorrhage confirmed by imaging were eligible).
- Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;
- Other conditions unsuitable for the enrollment, including but not limited to illiteracy, inability to complete the peripheral neurotoxicity scale, and other neurological abnormalities affecting the accurate assessment of neurotoxicity, etc.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: blank control group
No intervention.
|
|
|
실험적: compression glove/sock group
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
|
실험적: ice glove/sock group
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment
기간: 6 weeks
|
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
기간: 6 weeks
|
6 weeks
|
|
|
Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
기간: 6 weeks
|
6 weeks
|
|
|
Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
기간: 6 weeks
|
6 weeks
|
|
|
Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.
기간: 6 weeks
|
6 weeks
|
|
|
Number of participants with device-related adverse events
기간: 6 weeks
|
Number of participants experiencing adverse events related to the use of cryotherapy gloves/socks or compression gloves/socks, including skin injury, pain, discomfort, cold intolerance, numbness, and other device-related adverse events, assessed according to CTCAE v5.0.
|
6 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ting Li, fudan university shanghai cancer center shanghai, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .