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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04791254
Study type Observational
Source The Christie NHS Foundation Trust
Contact Alexandra Lewis
Phone +44 161 918 7887
Email alexandra.lewis12@nhs.net
Status Recruiting
Phase
Start date July 15, 2021
Completion date April 2026

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