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临床试验/NCT02412683
NCT02412683已完成不适用

Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer

Jenny Drott1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Oxaliplatin-Specific Neurotoxicity Scale

研究概览

简要总结

Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy. This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste disorders and swallowing difficulties.

The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients' daily lives and quality of life.

详细描述

Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy. This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste disorders and swallowing difficulties. A few studies on patients' experience of the neurotoxic symptoms and its impact on daily life.

The operative treatment of colorectal cancer is surgery. The possibility of curative resection is the factor most strongly associated to the patient's survival. High-risk patients and metastasis is not a contraindication for surgery of the primary tumor, but the individual patient's benefit from surgery must be especially valued. If the primary tumor does not cause any troublesome symptoms, and there are metastases in other organs, which can be treated with non-surgical methods, the tumor can be left initially and removed later if symptoms occur. For rectal cancer radiation therapy can be topical and reduces the risk of local recurrence. In locally advanced cancer in which radical resection is not possible, radiation therapy, with or without chemotherapy, be current in order to achieve tumor-killing effect of the infiltration zone. Radiation therapy can cause acute and chronic complications, such as pain, faecal incontinence and sexual dysfunction which may affect patients' quality of life.

At more advanced but radically operated colorectal cancer is commonly advised chemotherapy. The goal of giving chemotherapy is that, if possible, prevent micrometastasis that may exist in any patient, even though the patient is managed with radical surgery. Colorectal cancer spreads primarily to the lymph nodes and liver, but also through the bloodstream to the lungs, brain and bone. Choice of chemotherapy is influenced by several factors, including tumor extent, time from primary diagnosis, previous treatment given, symptoms, performance status, concomitant other diseases, blood tests and patient's own attitude towards such readiness to accept some side effects. Treatment intention can be curative, palliative or prophylactic (adjuvant). There are mainly three types of chemotherapy used to treat colorectal cancers. They can be individual, but is usually provided in combination. They can be given in multiple lines, which means that a combination can be administered initially and then changed to another combination of poor tolerance or treatment failure. Most patients get two or three lines of treatment.

Intended to provide combination therapy is to increase efficacy against the tumor, reducing the risk of resistance developing and spreading side effects. The effect of a particular treatment is best the earlier it is given but may be meaningful even at a later stage. A cornerstone of treatment for over five decades, 5-fluorouracil (5FU), which in colorectal cancer, in combination with folinic acid (leucovorin). This regime is relatively lowtoxic and most patients are capable of treatment without severe side effects. Capecitabine (Xeloda) is another treatment regimen, which is often preferred by patients because it is given orally and usually mild side effects. Another treatment option is to give oxaliplatin in addition to 5-flurouracil, leucovorin or capecitabine (FOLFOX 4, PHLOX, XELOX). These combinations are under trials to prolong survival compared with only 5-flurouracil and leucovorin. Oxaliplatin can reduce the risk of relapse by about 25 percent in comparison with 5FU/leukovorin. This regimen poses an increased proportion of neurotoxic side effects as a result. Chemotherapy can generally provide a number of unpleasant and sometimes life-threatening side effects. Side effects that may occur are symptoms of nausea, vomiting, diarrhea, anemia, skin lesions and mouth blown.

This can result in nutritional difficulties, reduced strength and impaired immune system with increased risk of infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
  • Ability to answer questions in swedish language
  • Ability to answer questions in mobile telephone

排除标准

  • Colorectal cancer patients in other regimes (palliative setting, no surgery)
  • Non ability to answer questions in swedish language
  • Non ability to answer questions in mobile telephone

结局指标

主要结局

Oxaliplatin-Specific Neurotoxicity Scale

时间窗: up to 12 months

次要结局

  • Health related quality of life (Fact-G) Questionnaire(up to 12 months)
  • Sense of Coherence scale (SOC-scale)(up to 12 months)

研究者

发起方
Jenny Drott
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Jenny Drott

RN, Ph-D student

Linkoeping University

研究点 (1)

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