Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480266
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-06
Brief Title:
Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy in Patients With Various Tumor Diseases
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pROtein
Brief Summary:
The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects Therefore with the pilot study presented here we would like to record the nutritional uptake of patients before and after radiotherapy The aim is to determine the amount of energy and protein intake as well as the timing of protein intake Furthermore the relationship between the timing of protein intake and muscle mass will be investigated
Detailed Description:
Many studies have shown that cancer patients have a very high prevalence of malnutrition Several large-scale studies have reported that 50-80 of these patients are affected by involuntary weight loss with the extent of weight loss depending on the tumor location and the type and stage of the disease It has been widely reported that nutritional interventions are essential in cancer patients Nevertheless nutritional support is still not universally accessible to all patients Given the prevalence of nutritional risks the treatment of lean muscle mass loss remains a challenge in clinical practice For this reason a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology A protein level of 1-12 gkg bw is suggested for the maintenance of muscle massHowever it has been shown that this amount is not sufficient to support ALM in patients with tumor diseases Only an amount above 14 gkg bw has been associated with a positive effect on muscle mass Adequate dietary protein intake is essential for the maintenance of numerous physiological processes including muscle protein synthesis and muscle function Sufficient energy and protein intake is necessary to support muscle protein synthesis The scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals The evening meal is particularly important for the maintenance of ALM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None