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临床试验/NCT06645067
NCT06645067尚未招募不适用

Cachectic Cancers and Adapted Physical Activity Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity

University of Rennes 21 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Exercise energy expenditure

研究概览

简要总结

  1. OBJECTIVE OF THE STUDY The study consists of evaluating resting energy expenditure (REE) and that induced by adapted physical activity (APA) in cachectic patients, compared with those predicted by equations and those of non-cachectic cancer patients. We will also seek to identify potential compensations in the level of Physical Activity (PA) and dietary intake during one week of the PA programme.
  2. CONDUCT OF THE STUDY Taking part in this study will in no way affect your treatment at SPORMED; you will undergo the same assessments and carry out the PAA programme in the same way. As a reminder, your treatment at SPORMED consists of an initial assessment session, a 12-week ABS programme and a final assessment session.

If you take part in the EMC2APA study, we will ask you to measure your gas exchange at rest (60 minutes) and during the aerobic part of one of your physical activity sessions. You will perform the effort traditionally targeted during the sessions (constant moderate intensity (60% of your Reserve Heart Rate, equivalent to a perception of the difficulty of the effort of 5-6/10) while your gas exchanges will be measured using a portable, non-invasive measuring device (K5, COSMED®). You will also be fitted with an accelerometric wristwatch.

In addition to the gas exchange measurements that will take place in the SPORMED structure, we will ask you to fill in a logbook tracking your daily physical activity and your daily food intake. You will also be asked to wear an accelerometer in a belt attached to your hip for 7 days.

Participation in this study is voluntary. There are no restrictions during the protocol.

详细描述

To stabilize patients' weight, it is essential to measure energy expenditure in order to propose appropriate nutritional and physical activity management (Purcell et al., 2016; Vazeille et al., 2017; Barcellos et al., 2021). In clinical practice, nutritional management is often based on predictive equations for end-stage renal disease (ESRD). These predictive equations include parameters such as age, height, weight, and sex. The most widely used is the Harris and Benedict equation, in which 85% of the healthy population has a resting energy expenditure (REE) between 90 and 110% of the predicted value. However, Barcellos et al. (2021) demonstrate that this equation underestimates REE by 648 kcal/day compared to values measured by indirect calorimetry in cancer patients. Predictive equations, therefore, seem obsolete for cancer patients, despite the central role of energy balance in treatment.

Several factors reduce the relevance of these equations and highlight the need for specific measurement of REE and total energy expenditure (TEE). Tumor type, size, and stage influence energy expenditure (Tuccar et al., 2021). A meta-analysis by Nguyen et al. (2016), including 27 studies, shows that REE increases by 9.66 kJ/kg fat-free mass (FFM)/day in cancer patients. REE can increase from 100 to 1400 kcal/day depending on tumor type (Purcell et al., 2016). However, tumor type directs the magnitude and direction of changes in energy metabolism. In a review by Hanna et al. (2023), the lean mass-adjusted REE shows that patients with high gastrointestinal cancers have higher REE than healthy individuals in 6 of the 9 studies, while the other 3 studies reported similar REE (Hanna et al., 2023). Tumors of the lung, head and neck, esophagus, stomach, liver, and pancreas are most affected by hypermetabolism (REE > 110% of predicted values), whereas melanoma, colorectal, and breast cancers show more normal metabolism (90 < REE < 110% of predicted values) or even hypometabolism (REE < 90% of predicted values) (Dempsey et al., 1984; Hanna et al., 2023; Tuccar et al., 2021; Purcell et al., 2016).

Determining the energy expenditure induced by physical activity (PA) in the presence of cachexia would allow for better nutritional management and contribute to further understanding of cancer cachexia management. Moreover, objectively assessing the different components of total energy expenditure (TEE), such as activity energy expenditure (AEE), would validate or challenge the use of predictive equations based on healthy individuals, identifying the specific needs of cachectic patients in terms of TEE and AEE induced by PA. Objective measurement of AEE will be more reliable than subjective estimates using questionnaires, which are prone to over- and under-estimation biases (Purcell et al., 2019). Altogether, this will enable more precise nutritional and PA recommendations for patients.

Objectives

The study aims to evaluate resting energy expenditure (REE) and PA-induced expenditure in cachectic patients compared to values predicted by equations and those in non-cachectic patients. The goal is also to assess potential compensatory effects on PA levels and daily intake during PA sessions.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be at least 18 years old.
  • Have understood the objectives of the study.
  • Have read and signed the consent form.
  • Be affiliated with a social security system.
  • Currently undergoing cancer treatment.

排除标准

  • Une fatigue extrême
  • Une anémie symptomatique (hémoglobine ≤ 8 g/dl)
  • Un syndrome infectieux sévère en cours d'évolution
  • Une décompensation de pathologie cardio-pulmonaire
  • La présence de lésions osseuses lytiques du rachis ou des os longs (la contre-indication concerne la mobilisation du membre atteint)
  • Une intolérance au port du masque de l'appareil K5 (Cosmed)

结局指标

主要结局

Exercise energy expenditure

时间窗: During an exercise session in the 5th week of the programme.

The measurement will be carried out on a treadmill ergometer and/or stationary bike. The exercise energy expenditure measurement will include a 7-minute warm-up with incremental intensity to reach a work level representing moderate effort in terms of RPE (5/10) or heart rate (60% of maximum heart rate), followed by 15 minutes of constant moderate-intensity exercise. A 2-minute recovery period will be added at the end to avoid abrupt physiological changes. The exercise energy expenditure measurement will take place after a period of familiarization with the cycle ergometer to minimize disturbances caused by stress or technical inefficiency.

次要结局

  • Physical Behavior : Sitting time(Over 8 days during the exercise program)
  • Resting Energy Expenditure(During the initial consultation before starting the exercise programme)
  • Physical Behavior : Moderate Physical Activity(Over 8 days during the exercise program)
  • Dietary Intake and Appetite(For 8 days during the exercise program)
  • Subjective Effort Perception(During Exercise Energy Expenditure assessment)
  • Heart Rate(During Exercise Energy Expenditure assessment)
  • Physical behavior : Vigorous Physical activity(Over 8 days during the exercise program)
  • Physical behavior : Walking duration(Over 8 days during the exercise program)
  • Physical Activity Counts(During Exercise Energy Expenditure assessment)
  • Daily Physical Activity Counts(For 8 days during the exercise program)

研究者

发起方
University of Rennes 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peyrachon Romane

MD

University of Rennes 2

研究点 (1)

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