The Use of Transcutaneous Electrical Nerve Stimulation (Tens) in Reducing Symptoms of Peripheral Neuropathy Induced by Antineoplastic Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.
研究概览
简要总结
This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have Chemotherapy-induced peripheral neuropathy (CIPN).
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) results from damage or dysfunction of the peripheral nerves and is one of the most common side effects of antineoplastic chemotherapy when neurotoxic drugs are used. Pain and paresthesia symptoms are prevalent, causing chronic discomfort and loss of functional abilities whilst also interfering negatively with quality of life and the patient's autonomy. In a pilot study of patients with CIPN, there was evidence that Transcutaneous Electrical Nerve Stimulation (TENS) improved the painful symptoms of patients with CIPN. This study aims to investigate the effects of TENS in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have CIPN.
- Primary Objectives Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.
Secondary Objectives:
- Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of paresthesia
- Evaluate the therapeutic response of TENS with frequency variation (FV) in activities of the daily lives of patients
- Evaluate the therapeutic response of TENS with frequency variation (FV) in symptoms of neuropathic pain.
- Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living.
Eligibility criteria: The participants of the research will include patients with any cancer diagnosis who are being subjected to chemotherapy in either adjuvant or neoadjuvant therapy, containing in its protocol at least one chemotherapeutic drug of moderate and high neurotoxic potential.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients who are being subjected to chemotherapeutic treatment with drugs or association of drugs with high and moderate neurotoxic degree and who present neuropathic pain and / or peripheral sensory neuropathy grade I and II of the CTCAE scale (Appendix A).
- •Patients showing symptoms of peripheral neuropathy in the first cycle of chemotherapeutic treatment with three points on the visual analogue scale of pain and paresthesia.
- •Patients aged between 18 and 70 years.
- •Patients without Diabetes Mellitus before and during chemotherapy treatment.
- •Patients who have not undergone previous chemotherapy regimens with neurotoxic drugs.
- •Patients with ECOG performance status ≤ 2 (Karnofsky ≥ 50%).
- •Patients that do not have a cardiac pacemaker.
- •Patients without changes in sensitivity prior to chemotherapy.
- •Patients without skin lesions at the site or around the site of application of the electrodes.
- •Patients without cognitive and comprehension difficulties.
- •Agree to participate in the study by signing the Free and Clarified Term of Consent- FCTC
排除标准
- •Patients who have already undergone chemotherapy previously with drugs or have had association with neurotoxic drugs which have presented neuropathic pain and/or sensory peripheral neuropathy.
- •Patients who have previously had acupuncture for the treatment of neuropathic pain and/or sensory peripheral neuropathy.
结局指标
主要结局
Evaluate the effects of TENS in the reduction of symptoms related to peripheral neuropathy due to chemotherapy treatment of a high and moderate neurotoxic potential in cancer patients.
时间窗: At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).
次要结局
- Evaluate the therapeutic response of TENS in activities of the daily lives of patients.(At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).)
- Evaluate the therapeutic response of TENS in symptoms of paresthesia(At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).)
- Evaluate the therapeutic response of TENS in symptoms of neuropathic pain.(At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).)
- Evaluate the factors associated with better treatment response in paresthesia, in pain and activities of daily living.(At each chemotherapeutic cycle, for the duration of three cycles (approximately 9 weeks).)