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临床试验/NCT05722223
NCT05722223已完成不适用

Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study

Puerta de Hierro University Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
To explore the feasibility of a trimodal prehabilitation program in the hospital setting

研究概览

简要总结

Pancreatic cancer is a disease with a very poor prognosis and less than 10% of these patients live beyond 5 years from diagnosis. Further, it is expected to become the second leading cause of death in the coming years. Today, surgery remains the cornerstone in curing this disease, but the addition of chemotherapy is needed to improve survival. The impact of adjuvant treatment has been previously demonstrated and its efficacy is absolute. However, neoadjuvant chemotherapy (pre-surgery) improves the results after surgery (achieving earlier stages and with better prognosis) and would lead to better survival results. Besides, the moment of cancer diagnosis is a moment of special receptivity to change lifestyles ("teachable moment").

Multimodal prehabilitation includes 1) physical exercise; 2) nutritional and 3) psychological support. The potential advantages of prehabilitation during neoadjuvant therapy would be 1) the possibility of achieving a better physical condition to face surgery; 2) fewer postoperative complications; 3) more likely to receive adjuvant treatment after surgery; 4) better physical function at the end of treatments. To date, most studies have focused on lung and prostate cancer, with a high prevalence of men in the series.

This strategy has previously been explored, showing that it is safe and feasible, (Loughney et al). We have not identified any study of trimodal prehabilitation during neoadjuvant treatment and none that has integrated motivational strategies to maintain adherence.

Patients during chemotherapy have perceived several adverse effects that could limit adherence to the program. In this regard, a review on the motivation and exercise in cancer survivors shows that it is necessary to apply theoretical frameworks to understand cognitive and motivational processes and develop educational interventions. The self-determination theory is one of the motivational theories most applied today to the analysis of factors related to the adoption of healthy lifestyles. Likewise, patients who are motivated are more likely to improve healthy habits and obtain greater adherence to exercise performance. Therefore, we aimed of carrying out an intervention (pilot study) in ten patients to describe the feasibility of a trimodal prehabilitation program in the hospital environment, applying motivational strategies and a mixed-method (face-to-face and online).

详细描述

outcome measures refer to feasibility of the intervention:

Recruitment Attendance to the training sessions Attendance to psychologist and nutritionist sessions

And also to physical condition Cardiorespiratory fitness Muscular strength Body composition Physical activity Quality of life Fatigue score

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
All
接受健康志愿者

入选标准

  • More than 18 years old
  • Being able to complete the mile-time test
  • Stages I-III
  • Being able to understand the informed consent
  • Pancreatic cancer diagnosed

排除标准

  • Metastasic cancer

结局指标

主要结局

To explore the feasibility of a trimodal prehabilitation program in the hospital setting

时间窗: 1 year

Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions

次要结局

  • Changes in body composition(3-6 months (from 1st treatment to surgery))
  • Changes in (estimated) cardiorespiratory fitness(3-6 months (from 1st treatment to surgery))
  • Changes in muscle strength(3-6 months (from 1st treatment to surgery))
  • Changes in body mass index(3-6 months (from 1st treatment to surgery))
  • Changes in levels of physical activity at week(3-6 months (from 1st treatment to surgery))
  • Changes in quality of life(3-6 months (from before1st treatment to surgery))
  • Describe changes in fatigue levels(3-6 months (from before 1st treatment to surgery))
  • Dose intensity in neoadjuvant treatment(3-6 months (from 1st treatment to surgery))
  • Describe post-surgical complications(three months)
  • Nutritional status(3-6 months (from 1st treatment to surgery))
  • Percentage of pathological complete responses(4-6 weeks after surgery)
  • Percentage of patients receiving adjuvant therapy(Three months after surgery)
  • Hindrances and facilitators of patients(During the prehabilitation program (3-6 months for each patient))
  • Anxiety and depression(3-6 months (from 1st treatment to surgery))

研究者

发起方
Puerta de Hierro University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Ruiz-Casado

Medical oncologist

Puerta de Hierro University Hospital

研究点 (2)

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