Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645067
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cachectic Cancers and Adapted Physical Activity Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMC2APA
Brief Summary:
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 5-610 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
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 5-610 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
Detailed Description:
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 kcalday 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 966 kJkg fat-free mass FFMday in cancer patients REE can increase from 100 to 1400 kcalday 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
General Hypotheses
Based on the literature cachectic patients are expected to exhibit hypermetabolism with REE values 110 of the values predicted by equations Additionally REE expressed as kcaldaykg of lean body mass is expected to be higher in cachectic patients compared to non-cachectic patients due to chronic inflammation and tumor-related energy expenditure
Regarding AEE no studies have focused on this parameter in cachectic patients TEE is mostly estimated using approximate predictive equations with only one study by Moses et al 2004 addressing TEE in cachectic patients This study aims to characterize energy expenditure induced by moderate-intensity exercise to adjust nutritional interventions according to patients PA levels
Regarding daily PA levels it is hypothesized that cachectic patients reduce daily PA on PA session days to compensate for energy expenditure Moses et al 2004 Additionally individuals are expected to increase their food intake to maintain energy balance and benefit from symptom reduction provided by PA
Assessment of Resting and Exercise Energy Expenditure REE and exercise energy expenditure EEE measurements are standardized at the SPORMED facility If consent is obtained Consent form in the appendix data may be transferred to a secure data collection file for analysis Data will be stored on an external password-protected hard drive and on the Huma-Num University data management server
Assessment of Eating and Physical Activity Behaviors Dietary behavior will be monitored over a 7-day period using a nutrition diary PA behavior duration and intensity including vigorous moderate light activity walking sedentary behavior and sleep duration will be measured using a validated accelerometer wGT3X worn at the hip If consent is obtained data will be transferred to a data collection file for analysis Handwritten dietary data will be digitized and accelerometer data will be extracted All data will be securely stored
Variables and Measurement Tools
Assessment of Resting and Exercise Energy Expenditure Using the K5 COSMED a portable non-invasive metabolic system for field and lab tests
Resting Energy Expenditure REE Patients will avoid moderate and vigorous PA for 24 hours before the measurement as well as a 4-hour fast No caffeine is allowed for 4 hours and no tobacco for 25 hours During the measurement patients will rest in a lying position for 30 minutes The measurement lasts 10 minutes once a stable state is reached oxygen consumption varies by less than 10 Rey 2018 The room temperature will be kept between 22 and 25C to limit environmental effects on energy expenditure Fullmer et al 2015
Exercise Energy Expenditure EEE Conducted on a treadmill or stationary bike the measurement includes a 7-minute warm-up with incremental intensity to reach moderate effort RPE 510 or 60 of max HR followed by 15 minutes of constant effort A 2-minute recovery will be included The data collected will help assess respiratory function and estimate energy expenditure using the Weir equation
Heart rate subjective effort perception and PA counts will also be recorded to compare energy expenditure estimates from predictive equations and activity monitors Dietary intake and appetite will be recorded daily in a nutrition journal with a 7-day monitoring period
Study Duration The number of subjects required was based on Moses et als 2004 study An estimated 5 patients per group are needed considering REE and EEE with a study duration of 7 months
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 966 kJkg fat-free mass FFMday in cancer patients REE can increase from 100 to 1400 kcalday 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
General Hypotheses
Based on the literature cachectic patients are expected to exhibit hypermetabolism with REE values 110 of the values predicted by equations Additionally REE expressed as kcaldaykg of lean body mass is expected to be higher in cachectic patients compared to non-cachectic patients due to chronic inflammation and tumor-related energy expenditure
Regarding AEE no studies have focused on this parameter in cachectic patients TEE is mostly estimated using approximate predictive equations with only one study by Moses et al 2004 addressing TEE in cachectic patients This study aims to characterize energy expenditure induced by moderate-intensity exercise to adjust nutritional interventions according to patients PA levels
Regarding daily PA levels it is hypothesized that cachectic patients reduce daily PA on PA session days to compensate for energy expenditure Moses et al 2004 Additionally individuals are expected to increase their food intake to maintain energy balance and benefit from symptom reduction provided by PA
Assessment of Resting and Exercise Energy Expenditure REE and exercise energy expenditure EEE measurements are standardized at the SPORMED facility If consent is obtained Consent form in the appendix data may be transferred to a secure data collection file for analysis Data will be stored on an external password-protected hard drive and on the Huma-Num University data management server
Assessment of Eating and Physical Activity Behaviors Dietary behavior will be monitored over a 7-day period using a nutrition diary PA behavior duration and intensity including vigorous moderate light activity walking sedentary behavior and sleep duration will be measured using a validated accelerometer wGT3X worn at the hip If consent is obtained data will be transferred to a data collection file for analysis Handwritten dietary data will be digitized and accelerometer data will be extracted All data will be securely stored
Variables and Measurement Tools
Assessment of Resting and Exercise Energy Expenditure Using the K5 COSMED a portable non-invasive metabolic system for field and lab tests
Resting Energy Expenditure REE Patients will avoid moderate and vigorous PA for 24 hours before the measurement as well as a 4-hour fast No caffeine is allowed for 4 hours and no tobacco for 25 hours During the measurement patients will rest in a lying position for 30 minutes The measurement lasts 10 minutes once a stable state is reached oxygen consumption varies by less than 10 Rey 2018 The room temperature will be kept between 22 and 25C to limit environmental effects on energy expenditure Fullmer et al 2015
Exercise Energy Expenditure EEE Conducted on a treadmill or stationary bike the measurement includes a 7-minute warm-up with incremental intensity to reach moderate effort RPE 510 or 60 of max HR followed by 15 minutes of constant effort A 2-minute recovery will be included The data collected will help assess respiratory function and estimate energy expenditure using the Weir equation
Heart rate subjective effort perception and PA counts will also be recorded to compare energy expenditure estimates from predictive equations and activity monitors Dietary intake and appetite will be recorded daily in a nutrition journal with a 7-day monitoring period
Study Duration The number of subjects required was based on Moses et als 2004 study An estimated 5 patients per group are needed considering REE and EEE with a study duration of 7 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None