Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy - a Monocentre, Single-arm Non-controlled Feasibility Study to Assess the Feasibility of Evaluating Topical Applications in CIPN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
Chemotherapy can cause sensory disorders in the hands and feet called peripheral neuropathy. Typical symptoms are pain, loss of sensation, tingling, numbness, and gait disturbances, which worsen patients' quality of life and increase the risk of falls. Little is known about the effect of rosemary oil (applied to hands and feet) on the symptoms of neuropathy. The present study is a feasibility study to see if it is possible to conduct a clinical trial in patients diagnosed with cancer and receiving chemotherapy who report peripheral neuropathy and apply rosemary oil to their hands and feet.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common severe dose-limiting side effects that accompany treatment with different chemotherapeutic agents. Patients with CIPN often experience a reduction in quality of life and an increase in fall risk due to symptoms such as pain, sensory loss, paresthesia (tingling, numbness), and gait disturbances. Treatment of CIPN is based on pharmacotherapy, which may in turn cause side effects such as nausea, dizziness, fatigue and others. In addition, various approaches from integrative medicine are used, e.g. acupuncture, touch therapies, mind-body medicine, dietary supplements, and aromatherapy. Little is known about the effect of rosemary oil, applied to hands and feet, on CIPN. The present study is a feasibility study to determine the feasibility of a future clinical trial to investigate the efficacy of topical application of rosemary oil in cancer patients undergoing chemotherapy who develop CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Written informed consent
- •Age 18 years or older
- •Cancer diagnosis
- •Assignment to neurotoxic chemotherapy that has not yet started at the time of enrolment
- •Intact, irritation-free skin on the hands and feet
- •No history of neuropathic pain
排除标准
- •Neurorelevant comorbidities such as diabetes or alcohol abuse
- •Use of medication for neuropathy such as gabapentin, pregabalin, venlafaxine or duloxetine
- •Other relevant treatments for CIPN during the study
- •Insufficient knowledge of the German language
- •History of rosemary oil allergy
研究组 & 干预措施
Rosemary oil
干预措施: Rosemary oil application (Other)
结局指标
主要结局
Participation rate
时间窗: When participation in the study is offered, before start of chemotherapy and rosemary oil application
Participation rate in relation to all eligible patients and the reasons for non-participation. Reasons for refusal to participate in the study will be recorded.
次要结局
- Rate of fully completed EORTC QLQ-CIPN20 questionnaires(Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks)
- Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire(Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks)