Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy
研究概览
简要总结
The purpose of this study is to examine the effect of supplementary polyunsaturated fatty acids on nerve damage in the body's extremitites of patients treated with oxaliplatin containing chemotherapy after surgery for colorectal cancer.
详细描述
The primary objective of the present study is to examine if a high dosage of n-3 PUFA reduces the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) 8 months after adjuvant oxaliplatin following surgery for high-risk colorectal cancer.
An additional aim is to investigate whether n-3 PUFAs have an effect on nutritional status, cognition and mental status. Inflammatory mechanisms and biomarkers of CIPN in skin biopsies and in blood will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin.
- •ECOG performance status 0-2 (measurement of a patient's function in terms of self-care, daily activity and physical ability.
- •Written and orally informed informed consent
排除标准
- •Inability to speak, read, and understand Danish.
- •Previous treatment with neurotoxic chemotherapy.
- •Neurological (including neuropathy) or psychiatric disorders, diabetes or other significant medical conditions.
- •Alcohol or drug abuse.
- •Sensory disturbances in the feet
- •Spinal stenosis.
- •Vascular disease (Fontaine grade II or more).
- •Known allergy to fish, fish oil or corn oil
- •Fertile patients not willing to use effective methods of contraception during treatment or abstinence.
- •Daily intake of oil supplements and not willing to stop during the trial period.
- •Lack of consent to skin biopsy
研究组 & 干预措施
Fish oil
4 capsules containing n-3 poly unsaturated fatty acids (EPA and DHA) with a total concentration of 3 g per day.
4 capsules per day for 8 months
干预措施: Fish oil (Dietary Supplement)
Corn oil
4 capsules containing n-6 poly unsaturated fatty acids in a total concentration of 2 g per day.
4 capsules per day for 8 months.
Corn oil is regularly used in the kitchen and the daily dose in the study is the equivalent of adding an extra spoon of food oil when cooking. It has no known effect on the parameters we want to examine.
干预措施: Corn oil (Dietary Supplement)
结局指标
主要结局
Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy
时间窗: 8 months after start of adjuvant chemotherapy
Number of patients who meet the criteria for CIPN: relevant symptoms evaluated by a medical doctor, incl one of the following: abnormal vibration test or, abnormal nerve conduction test by DPN check device or, abnormal pinprick test or, abnormal skin biopsy.
次要结局
- Change in severity of CIPN from baseline to 8 months after start of adjuvant chemotherapy according to the EORCT QLQ-CIPN 20 questionnaire(8 months after start of adjuvant chemotherapy)
- Intensity of CIPN-related neuropathic pain 8 months after adjuvant chemotherapy according to the Numeric Rating Scale (NRS)(8 months after start of adjuvant chemotherapy)