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RecruitingNCT04791254

Anorexia iN Cancer Patients: ANCHOR

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
Phase
Study type
Observational
Enrollment
450 (estimated)
Sponsor
The Christie NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

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.

Conditions

Timeline

Start date
2021-07-15
Primary completion
2025-04-01
Completion
2026-04-01
First posted
2021-03-10
Last updated
2023-02-08

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04791254. Inclusion in this directory is not an endorsement.