Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Malondialdehyde (MDA) as oxidative stress marker
研究概览
简要总结
This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.
详细描述
Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and nonpharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (study group) and Group B ( control group).
入排标准
- 年龄范围
- 8 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Their age will ranging from eight to forty years.
- •All cases participated in this study will from both sexes.
- •All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy
- •All cases have polyneuropathy caused by chemotherapy.
排除标准
- •Patient with osteoporosis.
- •Patient with DVT.
- •Patient have a Pacemaker fitted
- •Uncooperative patients
研究组 & 干预措施
The shockwave Group
Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months.
干预措施: The Shock wave Therapy. (Device)
the traditional treatment group
group (B) control group received medical care and standard chemotherapy only.
结局指标
主要结局
Malondialdehyde (MDA) as oxidative stress marker
时间窗: Malondialdehyde (MDA) level will be assessed at day 90.
Malondialdehyde level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
时间窗: Interlukin 6 (IL-6) level will be assessed at day 90.
Interlukin 6 (IL-6) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
时间窗: Plasma Neurotensin (NT)level will be assessed at day 90.
Plasma Neurotensin (NT) level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
时间窗: Interlukin 6 (IL-6) level was assessed at day 0.
Interlukin 6 (IL-6) level in blood will be measured
Malondialdehyde (MDA) as oxidative stress marker
时间窗: Malondialdehyde (MDA) level was assessed at day 0.
Malondialdehyde level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
时间窗: Plasma Neurotensin (NT)level was assessed at day 0.
Plasma Neurotensin (NT) level in blood will be measured
次要结局
未报告次要终点
研究者
Mohammed E. Ali, Ph. D Candidate.
Assistant Lecturer
South Valley University