NCT04095234进行中（未招募）2 期
Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- Worst Pain
研究概览
简要总结
The purpose of this study is to compare the long-term effectiveness of acupuncture versus massage in people living with advanced cancer. The study will test how the two approaches compare in helping people with pain and its related symptoms and improving 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
- Single (Outcomes Assessor)
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 years or older
- •Having a diagnosis of the following: stage III or IV lung cancer; any stage pancreatic cancer; unresectable cholangiocarcinoma; unresectable liver cancer; unresectable ampullary or peri-ampullary cancer or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer; stage IV genitourinary cancer; stage III or IV sarcoma; stage IV melanoma; stage III or IV head/neck cancer; stage IV endocrine cancer; or hematological malignancies (lymphoma, myeloma, and leukemia)
- •Be ambulatory (Karnofsky functional score of ≥ 60)
- •Having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or more generalized (fibromyalgia or chronic widespread pain); Patients with a neuropathic component to their pain that involves the extremities or back will be eligible.
- •Having musculoskeletal pain for at least 1 month
- •Having had pain for at least 15 days in the preceding 30 days
- •Having a pain rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week
- •Having an expected prognosis of greater than six months as judged by the treating oncologist or study physician
排除标准
- •Having a platelet count <15,000
- •Cognitive impairment precluding response to study assessments
- •Unwilling to accept random assignment
- •Unwilling to commit to the 26-week study time period
- •Have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.
结局指标
主要结局
Worst Pain
时间窗: 26 weeks from randomization
Worst Pain Item from the short-form Brief Pain Inventory (BPI). The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference).
次要结局
未报告次要终点
研究者
研究点 (16)
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