The Effect of Therapeutic Exercises on Balance, Quality of Life and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Balance assessment
研究概览
简要总结
To evaluate the effect of lower extremity strengthening and balance exercises on balance, quality of life and neuropathic pain of the cancer patients receiving neurotoxic chemotherapy.
详细描述
Cancer-related mortality rates decreased considerably thanks to novel treatment methods and new agents over the last two decades. Although chemotherapy (CT) is an effective treatment type in reducing the size of the tumor and eliminating metastases, it may harm many different organs and systems due to short & long-term side effects. Peripheral neuropathy (PN) is regarded as a neurological and clinical side effect for cancer patients. PN may arise as a paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short & long-term side effects that may damage sensory, motor, and autonomic neurons. This damage to the small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the damage to the large-fiber nerves causes a change in the sense of vibration and proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination, and damage to the autonomic nervous system affects intestinal motility and blood pressure over smooth muscles. Despite the fact that studies on PN treatment have generally focused on pharmacological agents reducing pain or treating selected side effects, no agent that may be preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic chemotherapy has been recommended in the review of the American Society of Clinical Oncology.
Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN may lead to impairment in the quality of life of the patient and may significantly reduce the level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance disorder, loss of function and reduced quality of life in the literature. It may result in loss of balance, difficulty in ambulation, increase in the frequency of collapse and accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are often helpful in the treatment of neuropathic pain, no effect has been observed on muscle strength, gait, and balance. It is believed that muscle strength and balance exercises, such as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood supply, thereby contributing to energy production and reducing symptoms. Current data suggest that exercise is applicable, safe, and beneficial for this group of patients. Balance exercises at an early stage may prevent or delay the onset of sensory and motor symptoms. Although exercise is accepted as a supportive treatment, which should be addressed more seriously for a patient population with PN, there is not enough information in the literature on timing, frequency, and mode of administration of the treatment program that will be carried out in this specific group of patients.
The aim of this study is to investigate the effects of therapeutic exercise program including concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance status and quality of life of the group of patients who have a limited physical activity, a risk of developing PN following the treatment, and will have a long-term bed rest and compare with the group of patients not receiving any exercise program in the same treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Non randomized, single blind, prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the ability to understand the informed consent form, and the signing the informed consent form after being informed in detail,
- •planned to have ≥3 cycles of neurotoxic chemotherapy (paclitaxel, docetaxel from taxane class agents, and cisplatin, oxaliplatin or carboplatin from platin group),
- •expected to have a survival of ≥6 months,
- •to have an Eastern Cooperative Oncology Group performance level between 0-2,
- •to have a full manual muscle strength.
排除标准
- •Previously diagnosed peripheral neuropathy (Diabetic peripheral neuropathy, entrapment neuropathies etc.)
- •Patients receiving medical treatment due to neuropathic pain (pregabalin, gabapentin, duloxetine etc.)
- •Pre-existing neurological disease
- •Pre-existing diabetes mellitus (>3 years or insulin use)
- •Alcoholism
- •HIV infection
- •Presence of peripheral vascular disease
- •Vitamin D or vitamin B12 deficiency
- •Non-ambulatory or refuse to practice exercise program
- •Visual or vestibular system impairment
- •Patients with central nervous system involvement or metastasis
研究组 & 干预措施
Exercise group
Eligible patients who were planned to receive neurotoxic chemotherapy
干预措施: Exercise (Other)
Control group
Patients eligible for the study and received the 3rd cycle of chemotherapy
结局指标
主要结局
Balance assessment
时间窗: 3 months
NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability.
次要结局
- Berg balance scale(3 months)
- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(3 months)
- PainDETECT: questionnaire(3 months)
研究者
Yeliz Bahar Ozdemir
Principal investigator
Hitit University
