Opioid-Sparing Pain Treatment In Myeloma And Lymphoma Patients Undergoing High-Dose Chemotherapy (OPTIMAL-HiChemo): Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 299
- 试验地点
- 3
- 主要终点
- the Number of Patients Using Opioids at a Given Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Acupuncture (Other)
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.
干预措施: opioid (Drug)
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.
干预措施: Assessments (Other)
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.
干预措施: opioid (Drug)
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.
干预措施: Assessments (Other)
结局指标
主要结局
the Number of Patients Using Opioids at a Given Time
时间窗: 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
Symptom Burden
时间窗: 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
次要结局
未报告次要终点