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Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative (PREHAREC)

2022年3月17日 更新者:Laura Mora-Lopez、Corporacion Parc Tauli

Randomized Controlled Trial Comparing the Effect of a Multimodal Prehabilitation Program During Neoadjuvant Treatment Versus a Multimodal Prehabilitation After Neoadjuvant Treatment for Patients Undergoing Resection of Rectal Cancer.

Control of the effect of prehabilitation on postoperative morbidity, assessed by the Comprehensive Complication Index (CCI), in patients diagnosed with rectal cancer that will receive neoadjuvant Quimiorradiotherapy (NCRT) and subsequent surgery, performed at the beginning of NCRT or before surgery.

研究概览

地位

尚未招聘

详细说明

According to the annual report of the Spanish Medical Oncology Association (SEOM), in Spain and without differentiating by sex, colorectal cancer will be the cancer with the highest incidence by 2021; with 43.581 new cases estimated for such year, 14.209 of these will be of rectal cancer. In rectal cancer, surgery remains the cornerstone; however, it is already known that local recurrences are frequent. That is why one of the main milestones rectal cancer treatment, is the multimodal therapy approach. It consists of implementing a neoadjuvant chemoradiotherapy treatment (NCRT) prior to surgical intervention. With this, local control of the disease is achieved, metastases are reduced have resulted in a five-year survival. Subsequently, depending on the definitive pathological results, patients should also complete treatment with postoperative chemotherapy. It is known that patients undergoing neoadjuvant treatment experience a wide variety of side effects, which can cause loss of muscle and cardiovascular function, loss of their functional capacity and increased fatigue. This worsens the quality of life of the patient and can sometimes cause the interruption of neoadjuvant treatment and have repercussions on the prognosis. Not only do these side effects affect the course of neoadjuvant treatment, but also declines the physiological reserve, making the patient arrive in sub-optimal conditions for surgery. This has an impact on postoperative morbidity and mortality, and secondarily, in the increase of hospital stay.

The concept of functional capacity appears ¨as the nutritional, physical and emotional state that a person has to face a stressful situation, such as surgical treatment. It is believed that if functional capacity is enhanced, postoperative morbidity can be reduced and the patient's recovery can also be improved. That is why trimodal programs are created, specifically selected for their potential cumulative or synergistic effects on health outcomes to prepare patients to face surgery at all three levels. These programs are known as prehabilitation.

Currently there are studies that show that prehabilitation improves the results of patients who must undergo different major surgical procedures, among them in colorectal surgery. Our group has recently presented a study that shows that trimodal prehabilitation contributes to reducing postoperative morbidity and overall hospital stay in patients operated on for colorectal neoplasia. There are also systematic reviews that conclude that prehabilitated patients who must undergo major surgery (speaking of 435 patients and 9 studies) present a decrease in the incidence of major postoperative complications. On the other hand, there are studies that show that prehabilitation in patients who must receive neoadjuvant therapy reduces the decrease of functional capacity that treatment produces on patients. As also shown by the Rex Trial, a randomized study on 48 patients. In an attempt to unite the two lines start the study, it will be a novel one , with only two previously published studies in this area. The intention is demonstrate that when prehabilitation is started before commencing neoadjuvant therapy in patients who are diagnosed with rectal cancer and who are subject to neoadjuvant therapy, will reduce the effect on functional capacity, and that patients will present less postoperative morbidity and better postoperative recovery.

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Barcelona
      • Sabadell、Barcelona、西班牙、08208
        • Laura Mora López

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient with rectal tumour and selected to initiate NRCT
  • Patient must know the study and sign informed consent.
  • Patient must accept the conditions necessaries to carry out the prehabilitation.

Exclusion Criteria:

  • Refusal of the patient to sign the informed consent.
  • Baseline pathology that makes it impossible to carry out prehabilitation.
  • Progression of the disease during the study period.
  • Emergency surgery.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
假比较器:PREHAB-PREOP
PREHABILITATION BEFORE SURGERY
Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery
实验性的:PREHAB-NEOADJ
PREHABILITATION DURING NEOADJUVANCY AND BEFORE SURGERY
Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Comprehension Complication Index (CCI)
大体时间:through study completion, an average of 1 yea
Morbidity after surgery of rectal cancer: CCI - value 0-100
through study completion, an average of 1 yea

次要结果测量

结果测量
措施说明
大体时间
6 minutes walking test (6MWT)
大体时间:through study completion, an average of 1 yea
Walking test that helps calculation of the number of daily steps to be carried out (5.000 to 10.000) daily steps
through study completion, an average of 1 yea
Hospital Anxiety and Depression Scale (HADS) test : anxious and depresion scale
大体时间:through study completion, an average of 1 yea
Calculation of level of anxiety or depression in mild, moderate or severe. Allows referral of the patient to the psychology service
through study completion, an average of 1 yea

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Laura Mora, Dr、Parc Taulí University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年3月1日

初级完成 (预期的)

2022年3月1日

研究完成 (预期的)

2025年3月1日

研究注册日期

首次提交

2022年2月9日

首先提交符合 QC 标准的

2022年3月17日

首次发布 (实际的)

2022年3月18日

研究记录更新

最后更新发布 (实际的)

2022年3月18日

上次提交的符合 QC 标准的更新

2022年3月17日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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