Effect of Local Heat and Cold Application in the Management of Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
研究概览
简要总结
Cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. The development of neuropathy not only restricts patients' physical functions but may also lead to dose reduction or even the discontinuation of chemotherapy.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons.
Although several potential agents have been clinically tested to prevent CIPN, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective. A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Studies investigating the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is effective in managing neuropathic symptoms.
This randomized controlled trial aims to evaluate the effects of local heat and cold application on neuropathic symptoms in breast cancer patients undergoing chemotherapy. Data will be collected using the Patient Information Form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and the Heat and Cold Application Patient Follow-up Form. Assessments will be conducted in both the intervention and control groups before the intervention and at the end of a 4-week period.
This study is designed as a randomized controlled trial to determine the effects of local heat and cold application on neuropathy in patients with chemotherapy-induced peripheral neuropathy.
详细描述
Breast cancer patients undergoing chemotherapy experience various side effects depending on the treatment protocol used. The most common side effects include neutropenia, anemia, peripheral neuropathy, nausea, vomiting, diarrhea, constipation, and fatigue. Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a dose-limiting and quality-of-life-reducing complication caused by chemotherapeutic agents. CIPN can develop either during or after chemotherapy and not only restricts patients' physical functions but may also lead to dose reduction or even treatment discontinuation.
Among chemotherapeutic agents, taxanes are among the most common causes of neuropathy. Docetaxel and paclitaxel, which belong to the taxane group, are widely used chemotherapeutics in the treatment of breast cancer. The incidence of taxane-induced peripheral neuropathy varies between 61% and 92%. Although taxane-induced neuropathy primarily presents with sensory symptoms, it is a toxicity that can also affect motor and autonomic functions. The degeneration, which manifests as numbness, tingling, and burning sensations in the fingers and toes, progresses from the distal to the proximal end of peripheral nerve axons. Neuropathy in the upper extremities typically appears later.
The neurotoxicity of taxane-induced neuropathy is dose-dependent, and progression ceases once the drug treatment is completed. Emerging symptoms can be prevented by reducing the drug dose or increasing the interval between doses. However, these adjustments may significantly compromise cancer treatment outcomes. Although numerous potential agents have been clinically tested to prevent chemotherapy-induced peripheral neuropathy, no pharmacological agent other than duloxetine, which has limited efficacy, has been proven effective.
A review of the literature reveals that non-pharmacological methods used in the management of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS), massage, exercise, heat and cold application, relaxation techniques, acupuncture, and reflexology. Medical baths have been used in the treatment of inflammatory and non-inflammatory rheumatic diseases, fibromyalgia, and chronic back pain, as well as for reducing fatigue and improving sleep regulation. In particular, foot bath studies have reported that foot baths increase blood circulation through vasodilation in peripheral blood vessels, improve sensory symptoms, stimulate the sense of touch, reduce sympathetic nerve activity, enhance skin permeability, promote microcirculation in cells, and support drug therapy.
A review of the literature indicates that very few studies have investigated the effects of foot baths on the management of peripheral neuropathy in cancer patients. Studies examining the effectiveness of local water baths in the treatment of neuropathy have reported that this approach is an effective strategy for managing neuropathic symptoms
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage III-IV breast cancer receiving 4-7 cycles of taxane-based chemotherapy,
- •Patients with chemotherapy-induced neuropathy symptoms,
- •Residents of Ankara,
- •Over 18 years older,
- •No history of nerve damage or psychiatric illness,
- •No central nervous system metastasis or disease,
- •No irritation or ulceration in the skin area where the application will be made,
- •No history of deep vein thrombosis,
- •Not using anticoagulant medication,
- •Able to speak, understand, and read/write in Turkish,
- •Patients who consent to participate in the study will be included.
排除标准
- •Patients with a history of nerve damage or psychiatric illness,
- •Ulcers or irritation in the area where the application will be made,
- •Patients with peripheral neuropathy developed due to reasons other than chemotherapy,
- •Patients who do not consent to participate in the study will be excluded.
- •Exclusion Criteria During the Study
- •Patients whose taxane treatment protocol is changed,
- •Patients who have less than four applications per week will be excluded from the study.
研究组 & 干预措施
Control group
standard protocol=Patients in this arm will receive standard care without any additional interventions related to heat or cold application.
Intervention group
Cold-Heat application + standard protocol
干预措施: Experimental- Heat application (Other)
Intervention group
Cold-Heat application + standard protocol
干预措施: Experimental-Cold application (Other)
结局指标
主要结局
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
时间窗: At baseline (first visit) and at 4 weeks
The Turkish validity and reliability of the scale were tested in breast cancer patients receiving taxane chemotherapy (n=430). The first section assesses sensory and motor symptoms (numbness, itching, burning, discomfort, cold sensitivity, pain, weakness, balance problems), with responses scored from 0 to 10. Higher scores indicate greater discomfort. In the second section, difficulties in daily activities (e.g., dressing, walking, working, exercising) are also rated from 0 to 10. The scale's overall Cronbach alpha is 0.87, with test-retest reliability ranging from 0.90 to 0.96. These results confirm that the scale is valid and reliable for the Turkish population.
Local Heat and Cold Application Patient Follow-up Form
时间窗: At baseline (first visit) and at 4 weeks
This form is designed to assess patients' adherence to local heat or cold application. During the heat or cold application process, patients will be followed up by phone to enhance their adherence to the program and ensure compliance. In addition, when patients come to receive their weekly chemotherapy doses, the application will be performed by the researcher. Patients will mark their heat or cold application status on the form while performing the application at home. The forms will be reviewed by the researcher when patients visit the hospital for chemotherapy treatment. Patients who perform the application less than four times per week will not be included in the evaluation.
次要结局
未报告次要终点
研究者
Sabahat Coşkun
Associate Professor Dr.
Bilecik Seyh Edebali Universitesi