Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791254
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2021-02-24
Brief Title:
Anorexia iN Cancer Patients ANCHOR
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
Anorexia iN Cancer Patients Assessment of the Gut HORmone and Cytokine Profile and Body Composition and the Impact of Dietetic Support in Patients With Gastrointestinal Cancer ANCHOR Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
ANCHOR
Brief Summary:
The rationale for this study is to prospectively investigate the outcomes of patients undergoing standard dietetic interventions alongside treatment for their advanced gastrointestinal cancers and to further characterise the relationship with body composition
A number of patients will be enrolled in a sub-study investigating the neuronal-enteroendocrine-hypothalamic axis
Gut hormone study Our hypothesis is that proinflammatory cytokines produced by the tumour can not only affect appetite directly through the vagal and the central melanocortin system but also indirectly though the enhanced EEC activity either through increased number or increased function
In this study the investigators will explore and compare the pattern and levels pre-prandial and post prandial of the pro-inflammatory cytokines and gut hormones between stage-standardised anorexic and non-anorexic cancer patients and age-matched healthy controls
A number of patients will be enrolled in a sub-study investigating the neuronal-enteroendocrine-hypothalamic axis
Gut hormone study Our hypothesis is that proinflammatory cytokines produced by the tumour can not only affect appetite directly through the vagal and the central melanocortin system but also indirectly though the enhanced EEC activity either through increased number or increased function
In this study the investigators will explore and compare the pattern and levels pre-prandial and post prandial of the pro-inflammatory cytokines and gut hormones between stage-standardised anorexic and non-anorexic cancer patients and age-matched healthy controls
Detailed Description:
Poor nutritional status contributes significantly to poor outcomes in patients with upper GI cancers in some patients directly leading to death Poor fitness in terms of reduced muscle mass sarcopenia or physical performance is associated with higher treatment toxicity and poor treatment outcomes
However the relationship between different markers of nutritional status and body composition with fitness is not fully understood It is also not known what impact dietetic interventions have on the reduced survival seen in patients with weight loss at baseline
Finally the underlying interaction between the neuronal-enteroendocrine-hypothalamic axis that regulates appetite is poorly understood but believed to be impaired in patients with upper GI cancers because of a number of altered mechanisms
Therefore the rationale for this study is to prospectively investigate the outcomes of patients undergoing standard dietetic interventions alongside treatment for their advanced gastrointestinal cancers and to further characterise the relationship with body composition
A number of patients will be enrolled in a sub-study investigating the neuronal-enteroendocrine-hypothalamic axis
The hypothesis is that proinflammatory cytokines produced by the tumour can not only affect appetite directly through the vagal and the central melanocortin system but also indirectly though the enhanced EEC activity either through increased number or increased function
In this study the investigators will explore and compare the pattern and levels pre-prandial and post prandial of the pro-inflammatory cytokines and gut hormones between stage-standardised anorexic and non-anorexic cancer patients and age-matched healthy controls
However the relationship between different markers of nutritional status and body composition with fitness is not fully understood It is also not known what impact dietetic interventions have on the reduced survival seen in patients with weight loss at baseline
Finally the underlying interaction between the neuronal-enteroendocrine-hypothalamic axis that regulates appetite is poorly understood but believed to be impaired in patients with upper GI cancers because of a number of altered mechanisms
Therefore the rationale for this study is to prospectively investigate the outcomes of patients undergoing standard dietetic interventions alongside treatment for their advanced gastrointestinal cancers and to further characterise the relationship with body composition
A number of patients will be enrolled in a sub-study investigating the neuronal-enteroendocrine-hypothalamic axis
The hypothesis is that proinflammatory cytokines produced by the tumour can not only affect appetite directly through the vagal and the central melanocortin system but also indirectly though the enhanced EEC activity either through increased number or increased function
In this study the investigators will explore and compare the pattern and levels pre-prandial and post prandial of the pro-inflammatory cytokines and gut hormones between stage-standardised anorexic and non-anorexic cancer patients and age-matched healthy controls
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?:
None
Is an FDA AA801 Violation?:
None