此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

治疗骨髓瘤或淋巴瘤患者化疗引起的疼痛和症状负担

2026年10月7日 更新者：Memorial Sloan Kettering Cancer Center

接受高剂量化疗 (OPTIMAL-HiChemo) 的骨髓瘤和淋巴瘤患者的阿片类药物保留疼痛治疗：随机对照试验

The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

299

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New York
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
    • Washington
      • Seattle、Washington、美国、98109
        • Seattle Cancel Care Alliance (Data Collection Only)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • age 18 or older
  • pathological diagnosis of MM, HD or NHL
  • scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days)
  • not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed)

Exclusion Criteria:

  • absolute neutrophil count (ANC) of <500/μl, platelet count of <20,000/ μl or INR >2.0
  • acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture)
  • unable to provide informed consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Usual Care plus Acupuncture

Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief.
其他：Acupuncture

Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice.

药品：opioid

All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.

其他：Assessments

Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
有源比较器：Usual Care

Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care.
药品：opioid

All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.

其他：Assessments

Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
the Number of Patients Using Opioids at a Given Time
大体时间：at day 7

at a given time divided by the total number of patients randomized to that group at Day 7) by review of medication records and urine drug test
at day 7
the Number of Patients Using Opioids at a Given Time
大体时间：at day 90

at a given time divided by the total number of patients randomized to that group at Day 90) by review of medication records and urine drug test
at day 90
Symptom Burden
大体时间：At baseline

measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
At baseline
Symptom Burden
大体时间：At Day 7

measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
At Day 7
Symptom Burden
大体时间：At Day 90

measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
At Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Memorial Sloan Kettering Cancer Center

合作者

Patient-Centered Outcomes Research Institute
Hackensack Meridian Health

调查人员

  • 首席研究员：Jun Mao, MD, MSCE、Memorial Sloan Kettering Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月30日

初级完成 (实际的)

2024年7月2日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2020年7月1日

首先提交符合 QC 标准的

2020年7月1日

首次发布 (实际的)

2020年7月7日

研究记录更新

最后更新发布 (实际的)

2026年10月9日

上次提交的符合 QC 标准的更新

2026年10月7日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20-264

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅