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临床试验/NCT07307690
NCT07307690尚未招募不适用

Comparison of the Effectiveness of 8-week vs 12-week Physical Exercise Programmes in Patients With Colorectal Cancer

University of Salamanca0 个研究点目标入组 50 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Chemotherapy-induced neuropathy

研究概览

简要总结

Chemotherapy is a cornerstone in the treatment of colon cancer; however, its effects extend beyond malignant cells. Because chemotherapeutic agents target rapidly dividing cells, they can also damage healthy tissues, resulting in a range of adverse effects. Among the most prevalent is peripheral neuropathy, a disorder of the peripheral nervous system characterized by symptoms such as tingling, numbness, pain, and weakness in the extremities.

Chemotherapy-induced peripheral neuropathy poses a significant challenge for patients with colon cancer, as it further compromises quality of life during an already demanding phase of treatment. Damage to sensory and motor nerves interferes with the ability to perform daily activities and diminishes physical capacity, thereby intensifying both the physical and psychological burden associated with the disease.

Nevertheless, certain interventions may help mitigate these negative effects, with physical exercise emerging as a particularly promising strategy. Although it may appear counterintuitive, regular physical activity has been shown to exert beneficial effects on peripheral neuropathy. Exercise enhances blood circulation, supports the regeneration of damaged peripheral nerves, and helps reduce neuropathic pain and discomfort, ultimately improving functional performance.

It is important to emphasize that exercise interventions should be individually tailored and conducted under appropriate medical supervision. Consequently, the integration of chemotherapy with a carefully designed exercise program represents a comprehensive approach to managing both the disease and its treatment-related side effects, contributing to an improved quality of life for patients with colon cancer throughout their recovery process.

详细描述

1. Introduction Colon cancer is one of the leading causes of morbidity and mortality worldwide, with an increasing incidence in many developed countries. In Spain, it is one of the most common types of cancer, accounting for approximately 15% of all cancer cases diagnosed, with an incidence of around 41,000 new cases annually. The mortality associated with colon cancer is significant, although there have been notable improvements in five-year survival rates, which currently stand at around 65%, thanks to advances in treatments and early diagnosis. Early diagnosis is crucial and has been facilitated by screening programs such as colonoscopy and fecal occult blood tests, which allow the detection of precancerous lesions and early-stage cancer. Treatments for colon cancer include surgery, radiotherapy, immunotherapy, and notably, chemotherapy. Chemotherapy is especially relevant in adjuvant treatment to reduce the risk of postoperative recurrence and in metastatic disease to control tumor growth and prolong survival. Modern chemotherapeutic agents, combined with targeted and supportive therapies, have significantly improved treatment outcomes, providing patients with better recovery prospects and an enhanced quality of life during and after treatment.

Chemotherapy is a crucial treatment in the fight against colon cancer, but unfortunately, its impact is not limited solely to cancer cells. Chemotherapeutic agents, designed to target rapidly growing cells, also affect healthy tissues, leading to various side effects. One of the most common adverse effects is peripheral neuropathy, a condition that affects the peripheral nerves and can manifest as sensations of tingling, numbness, pain, or weakness in the limbs. Chemotherapy-induced peripheral neuropathy can be especially challenging for patients with colon cancer, as it further worsens the quality of life during an already difficult period. The nerves responsible for motor and sensory function are compromised, affecting the patient's ability to perform daily activities and weakening their physical endurance.

This phenomenon adds to the emotional and physical burden of battling cancer. However, there are tools that can positively influence these adverse effects, such as physical exercise. Although it may seem contradictory, regular physical exercise has been shown to have beneficial effects on peripheral neuropathy. Physical exercise can improve blood circulation and promote the regeneration of damaged peripheral nerves.

Additionally, exercise helps alleviate the pain and discomfort associated with neuropathy, thereby strengthening patients' functional capacity.

Scientific research has demonstrated that physical exercise has multiple benefits for cancer patients, beyond alleviating peripheral neuropathy. Various studies have indicated that regular physical activity can significantly improve immune function, which is crucial for patients undergoing treatments that weaken the immune system. Exercise helps increase the production and efficiency of immune cells, enhancing the body's ability to fight infections and potentially inhibiting the growth of cancer cells.

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
Double (Investigator, Outcomes Assessor)

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

  • People diagnosed with colorectal cancer and who are receiving chemotherapy treatment.
  • Sedentary people who have not performed physical activity in the last 8 weeks.
  • Ability to understand the evaluation tests and the performance of the exercises.
  • Presence of XXX symptoms (If we focus on neuropathy, it should be inclusion criteria).
  • Voluntary participation in the study.

排除标准

  • - Present contraindication/s for physical exercise (musculoskeletal diseases, severe cardiovascular disease, bone metastases,...).

研究组 & 干预措施

Exercise group

Experimental

The investigators propose a 8 vs 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.

干预措施: Exercise (Other)

Exercise group

Experimental

The investigators propose a 8 vs 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.

干预措施: Physical activity recommendations (Other)

Control group

Experimental

They will be provided with clear and concrete recommendations of activities for the user to perform the rest of the days of the week in order to increase their level of physical activity and increase weekly metabolic expenditure.

干预措施: Physical activity recommendations (Other)

结局指标

主要结局

Chemotherapy-induced neuropathy

时间窗: Baseline and immediately after the intervention

The EORTC CIPN20 questionnaire will be used.This questionnaire contains 20 items on which patients rate their experience for each symptom during the previous week using scores from 1 (not at all) to 4 (very much). The sum score was obtained by adding the scores of items 1 to 19 resulting in a sum score range of 19 to 76, which was termed CIPN20 sum1-19.

次要结局

  • Wellbeing(Baseline and immediately after the intervention)
  • Mental health(Baseline and immediately after the intervention)
  • Body Mass Index(Baseline and immediately after the intervention)
  • Sleep quality(Baseline and immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CARLOS MARTIN SANCHEZ

PhD

University of Salamanca

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