The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 主要终点
- Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
研究概览
简要总结
Study Design:
This study is designed as a prospective, randomized controlled experimental study aiming to determine the effect of cryocompression therapy, applied during chemotherapy, on peripheral neuropathy symptoms in women with gynecologic cancers.
Research Hypotheses:
- H₀: Cryocompression therapy has no effect on peripheral neuropathy.
- H₁: Cryocompression therapy has an effect on peripheral neuropathy.
Study Population:
The study population will consist of women over the age of 18 living in Mersin, Türkiye, who are diagnosed with gynecologic cancer and undergoing chemotherapy between August 10 and December 31, 2025.
详细描述
This study will be conducted with women diagnosed with gynecological cancer who apply to the Oncology Outpatient Clinic and Ambulatory Chemotherapy Unit of Mersin University Hospital and voluntarily agree to participate in the research.
The sample size was calculated using the G*Power 3.1.9.7 program, based on the Chi-Square Test of Independence. In a previous study, the incidence of peripheral neuropathy was reported as 28.2% in the cold therapy group and 57.5% in the control group. Using these data, with a 5% margin of error (α = 0.05) and 80% power (1-β = 0.80), the required sample size was determined to be 35 participants per group. Considering potential data loss, the sample size in each group was increased by approximately 10%, resulting in 39 participants per group. A total of 78 participants will be included in the study.
Inclusion Criteria:
Age 18 years or older,
Diagnosed with gynecological cancer,
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Applying to Mersin University Hospital Oncology Outpatient Clinic
- •Willing to participate and providing signed informed consent
- •Able to read and write in Turkish
- •Accessible and able to communicate
- •Citizen of the Republic of Türkiye
- •Diagnosed with gynecologic cancer (ovarian, endometrial, or cervical) and aged ≥18 years
- •Receiving weekly carboplatin + paclitaxel chemotherapy protocol
- •No subjective peripheral neuropathy symptoms before starting chemotherapy
- •No history of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols
- •No psychiatric disorders
- •No diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia
排除标准
- •Not applying to the specified outpatient clinic
- •No gynecologic cancer diagnosis or younger than 18 years old
- •Not providing informed consent
- •Not receiving weekly carboplatin + paclitaxel chemotherapy protocol
- •Presence of subjective peripheral neuropathy symptoms before starting chemotherapy
- •History of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols
- •Presence of psychiatric disorders
- •Having diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia
结局指标
主要结局
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
时间窗: One week after each chemotherapy cycle (6 weeks total).
Change in peripheral neuropathy severity measured by the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) Scale range: 0 to 80 (higher scores indicate more severe neuropathy symptoms). Time Frame: One week after each weekly chemotherapy cycle, for six cycles (total 6 weeks). Description: Peripheral neuropathy severity will be assessed using the CIPNAT scale, which evaluates sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores from all six cycles will be summed for analysis.
次要结局
未报告次要终点
研究者
burcu okayer özer
MSc, PhD(c), Registered Nurse
Mersin University