Implementation and Evaluation of a New Cancer Rehabilitation Process for the Assessment and Treatment of Chemotherapy-Induced Foot Neuropathy - A Collaborative Project Between Oncology Clinic and Orthopedic Technology Department 2.0.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
研究概览
简要总结
The goal of this clinical study is to evaluate a new process for assessing and alleviating chemotherapy-induced peripheral neuropathy in the feet in patients treated with chemotherapy for early stage breast cancer. It will also compare two orthopedic interventions for symptom relief. The main questions it aims to answer are:
Can an orthopedic silicone orthosis reduce chemotherapy-induced peripheral neuropathy symptoms in the feet? How does the effectiveness of the silicone orthosis compare to standard orthopedic treatment with insoles and shoes?
Participants will:
Use either a silicone orthosis or standard orthopedic treatment Have contact with the clinic for assessments and follow-ups Report their symptoms and functional improvements over time
详细描述
Background and Rationale
This study aims to develop and evaluate a structured multidisciplinary rehabilitation process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet. The project establishes a new collaboration between the Oncology Department and the Department of Orthopedic Technology at Sahlgrenska University Hospital, integrating an orthopedic approach into cancer rehabilitation.
Chemotherapy-induced peripheral neuropathy is a common side effect of chemotherapy, affecting 50-90% of patients undergoing cancer treatment. Symptoms such as numbness, tingling, pain, and sensory loss in the feet can lead to chronic discomfort, impaired balance, and reduced quality of life. Despite its prevalence, there are no standardized guidelines for grading or managing chemotherapy-induced peripheral neuropathy within rehabilitation. Additionally, structured follow-up for chemotherapy-induced peripheral neuropathy after chemotherapy is lacking in Sweden, and there are limited effective treatment options available.
This research project aims to develop a structured process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet and to evaluate two orthopedic interventions:
- Current standard treatment - customized insoles and orthopedic shoes.
- A novel intervention - a silicone orthosis, designed as a soft, sock-like device for indoor use.
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
- •Patients with breast cancer receiving treatment at the Oncology Department, Sahlgrenska University Hospital (SU).
- •Have undergone treatment with taxanes.
- •Aged 18 years or older.
- •Able to understand spoken and written Swedish.
- •Patients who can ambulate with or without assistive walking devices.
- •CTCAE grading above 2 at a medical visit after completing treatment.
排除标准
- •Bilateral amputation at the thigh level.
- •Previously diagnosed neurological disease or neurological impairment affecting the feet.
研究组 & 干预措施
Standard orthopedic treatment
Patients provided with customized shoes and insoles for outdoor use
干预措施: Standard Treatment (Device)
Silicone orthose
Patients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use.
干预措施: Silicone orthosis (Device)
结局指标
主要结局
Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
时间窗: At baseline and after three to six weeks after treatment initiation
Neuropathy severity will be assessed using the NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0, a standardized tool for grading adverse events related to cancer treatment, including chemotherapy-induced peripheral neuropathy (CIPN). CIPN is classified into five grades based on motor, sensory, and autonomic symptoms: Grade 1 (Mild): Asymptomatic or mild symptoms with no significant impact on daily activities. Grade 2 (Moderate): Symptoms affecting daily activities but not requiring intervention. Grade 3 (Severe): Symptoms severely limiting self-care and daily functions. Grade 4 (Life-threatening): Disabling symptoms requiring urgent intervention. Grade 5 (Fatal): Death related to adverse effects. Higher grades indicate more severe neuropathy and are used to monitor patient safety, adjust treatments, and evaluate drug toxicity in clinical oncology settings.
Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.
时间窗: During two weeks after initiation of treatment
The device records movement patterns and classifies activity into three main categories: Sedentary time (e.g., sitting or lying down) Standing time Stepping time (walking or other movement) The data is collected over a period of two weeks, allowing researchers to analyze changes in mobility and activity levels. The first few days serve as an adaptation phase, after which the measurements are expected to reflect habitual daily activity. The digital activity data is often combined with patient diaries to provide a more comprehensive analysis of movement patterns and intervention effects.
Change in foot neuropathy symptoms after 3-6 weeks of using the silicone orthosis.
时间窗: At baseline and after 3-6 weeks after initiation of treatment.
The modified CIPN20 questionnaire is a tool for assessing chemotherapy-induced peripheral neuropathy symptoms and their impact on daily life. It consists of 20 items, covering sensory (9 items), motor (8 items), and autonomic (3 items) domains. Each item is rated on a 5-point Likert scale: 0 = Not at all 1. = A little 2. = Somewhat 3. = Quite a bit 4. = Very much Higher scores indicate more severe symptoms and functional impairment. The scores can be analyzed separately for each domain or as a total CIPN burden, making the questionnaire useful for monitoring symptom progression and evaluating treatment effects.
次要结局
- Change in self reported quality of life in patients with foot neuropathy after 3-6 weeks of using the silicone orthosis.(At enrollment and after three to six weeks after treatment initiation)
- Comparisons of foot status based on a structured foot examination.(The comparison is based on a one-time examination at enrollment.)
- Differences in foot anthropometry between study group and a control group representing a female Swedish normal population(The comparison is based on a one-time examination at enrollment.)