Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
研究概览
简要总结
This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy.
The name of the device used in this research study is:
-Paxman Limb Cryocompression System (PLCS)
详细描述
This randomized controlled trial aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy.
The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompression System as a treatment to reduce peripheral neuropathy.
Participants will be randomized into 1 of 2 groups: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy versus Arm B: Standard of Care Taxane-Based Chemotherapy. Participants will be randomized in a 2:1 manner, meaning a participant is 2 times the chance (approximately 67%) of being in Arm A than in Arm B (approximately 33%). Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-clinic visits, and questionnaires.
It is expected that about 50 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adults > 18 years of age
- •Gynecologic or breast malignancy
- •Starting 1st cycle of treatment with chemotherapy regimens:
- •Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology)
- •Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)
- •Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)
- •Able to complete questionnaires in English or Spanish
排除标准
- •Previous exposure to neurotoxic chemotherapy
- •Pre-existing neuropathy
- •History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
- •Undergoing desensitization
- •Lymphedema in the limb where the device would be applied
- •Open skin wounds or ulcers of the limbs where the device would be applied
研究组 & 干预措施
Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy
Participants will be randomized and stratified by chemotherapy regimen and will complete:
- Baseline visit with questionnaires
- Standard of care chemotherapy visits with cryocompression
- End of treatment visit
干预措施: Paxman Limb Cryocompression System (Device)
Arm B: Standard of Care Taxane-based Chemotherapy
Participants will be randomized and stratified by chemotherapy regimen and will complete:
- Baseline visit with questionnaires
- Standard of care chemotherapy visits
- End of treatment visit
结局指标
主要结局
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
时间窗: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks
This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy
时间窗: Up to 12 weeks
Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.
Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment
时间窗: Assessed 1-4 weeks after the final taxane infusion (end of treatment).
Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20). This aim is defined as evaluating the incidence and severity of subjectively reported CIPN symptoms, including numbness, tingling, and pain in hands and feet. Clinically significant CIPN is expected to emerge during taxane-based treatment and will be captured at the follow-up visit post-treatment.
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy
时间窗: Up to 12 weeks
Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression
时间窗: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks
This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.
次要结局
未报告次要终点
研究者
Theresa Jabaley, PhD
Principal Investigator
Dana-Farber Cancer Institute