Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Feasibility - Ability to complete daily 30-minute cryocompression treatments
研究概览
简要总结
This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands or feet) is a common side effect of chemotherapy such as bortezomib that affects the quality of life and amount of chemotherapy that can be given to many cancer patients. Cryocompression is a treatment where a glove and a boot are worn to cool down the skin. This cooling treatment is safe and does not interfere with chemotherapy treatment. Daily cryocompression therapy may reduce neuropathy caused by bortezomib chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility of daily cryocompression therapy in multiple myeloma patients with bortezomib-induced peripheral neuropathy (BIPN).
SECONDARY OBJECTIVES:
I. To examine the change in patient-reported assessment of neuropathy based on the sensory, motor and autonomic neuropathy scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Cancer-Induced Peripheral Neuropathy (CIPN20) (patient-reported outcome [PRO]) from baseline to 4 and 8 weeks after the start of cryocompression therapy.
II. To examine the change in physician graded assessment of peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 criteria from baseline to 4 and 8 weeks after the start of cryocompression therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System [ISS] stage).
- •Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE.
- •Cohort 1: Patients with clinically documented CTCAE grade greater than or equal 2 neuropathy.
- •Cohort 2: Patients with clinically documented CTCAE grade 1-2 neuropathy.
- •Currently or previously received bortezomib-containing regimen
- •Cohort 1: Patients who have previously received a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
- •Cohort 2: Patients who are currently receiving a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
- •Age must be greater than or equal to 18 years.
- •Eastern Cooperative Oncology Group (ECOG) =<
- •Life expectancy >= 6 months.
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.
排除标准
- •Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy.
- •Other explanatory etiology for neuropathy.
- •Presumptive evidence of congestive heart failure.
- •Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months).
- •Current pulmonary edema.
- •Unable to provide accurate medical history.
- •Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria.
- •Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease;
- •Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.
结局指标
主要结局
Feasibility - Ability to complete daily 30-minute cryocompression treatments
时间窗: Baseline up to 8 weeks of cryocompression therapy
The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured by VCU recorded data. Patient study treatment diary will be compared and when discrepancies exist, resolved either by asking the patient or discussing with the study principal investigator. Compliance is defined as completion of 60% of prescribed treatment days. Completion of at least 25 of 30 minutes on each day will be considered completion of therapy on the prescribed day. Analyses will be primarily descriptive to estimate variances and effect sizes for future work. The proportion of compliance and its 95% confidence interval will be calculated for each cohort.
次要结局
- NCI-CTCAE v5.0 Severity Grade Changes(Baseline up to 8 weeks of cryocompression therapy)
- Change in Sensory Response(Baseline and after 8 weeks of cryocompression therapy)
- EORTC QLQ-CIPN20 Questionnaire(Baseline up to 8 weeks of cryocompression therapy)
- Change in Motor Nerve Function(Baseline and after 8 weeks of cryocompression therapy)