The Preliminary Effects of Henna on Chemotherapy-Induced Peripheral Neuropathy in Women Receiving Oxaliplatin Based Treatment: A Parallel Group Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common long-term toxicities of chemotherapy. Though, CIPN is one of the common symptoms encountered by oncology nurses in care of patients. For this reason, there is a need for an intervention that could decrease or prevent of CIPN.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is frequently seen in patients receiving oxaliplatin-based therapy.This parallel group randomized controlled pilot clinical trial aimed at investigating the feasibility and preliminary effect of henna on CIPN in women receiving oxaliplatin-based therapy. This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received oxaliplatin-based therapy in the oncology clinic every fifteen days.
In order to calculate the sample size, it was decided to recruit 30 female patients to each group (intervention and control) using the G.Power-3.1.9.2 program. A total of 60 female patients were included in the study.
The study consists of two groups. In the intervention group, after the 2nd and 3rd chemotherapy cycles, henna application was applied to the hand-foot and toes. The control group underwent only the routine treatment.
To collect data, a personal information form and Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) were used.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years and older women
- •Must the level of neurotoxicity is Stage II and Stage III
- •Must taken at least one chemotherapy cycle and is planned to continue 2 chemotherapy cycles
- •Be taking Folfox-6 chemotherapy protocol
排除标准
- •Having an open wound and edema in the hands and feet
- •Having a peripheral neuropathy due to diabetes and autoimmune diseases
- •Using any complementary and alternative (CAM) treatment method to prevent peripheral neuropathy during administration
结局指标
主要结局
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT
时间窗: It was filled before the 2nd, 3rd and 4th chemotherapy cycles (each cycle is 15 days). Change from baseline Chemotherapy-Induced Peripheral Neuropathy Assessment Tool scores at 6 weeks.
It was developed by Tofthagen et al. (2011) to evaluate chemotherapy-induced peripheral neuropathy. It consists of two sections. The first section concerns nine symptoms; the severity of these symptoms, the possibility of an emotional problem occurring, and the incidence rate of these symptoms are evaluated. The first six questions in this section constitute the sensory symptoms, and the seventh, eighth and ninth questions constitute the subdimensions of motor symptoms. In the second section, fourteen (sensory and motor) activities were evaluated, including whether they were affected by the symptoms. The total score to be obtained from the scale is between 0 and 279. High scores indicate severe symptoms, high rate of incidence, many emotional problems and limitations on daily life activities.It was tested for validity and reliability on Turkish population by Kutluturkan et al. (2017), with Cronbach's alpha reliability coefficient of 0.95.
次要结局
未报告次要终点
研究者
Pinar Zorba Bahceli, PhD RN
Asistant Professor
Selcuk University