Gastric Cancer, Oesophageal Cancer
Conditions
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.
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.
Interventions
None listed
Sponsors
University of Manchester
Manchester Metropolitan University
The Christie NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Inclusion criteria: Cohort A 1. Patients with stage IV gastric or GOJ adenocarcinoma or locally advanced non-resectable adenocarcinoma 2. Histologically proven adenocarcinoma, squamous cell carcinoma or poorly differentiated carcinoma 3. Patients should be chemotherapy or immune therapy naïve (for their current diagnosis). 4. Patient must be 18 years of age or above. 5. Patient must be able to understand the study information given to them and be willing to give consent for trial participation. 6. Patients should be commencing a course of palliative chemotherapy treatment with the upper GI team at the Christie Hospital In addition the above patients enrolled in cohort B must meet the following criteria Inclusion criteria: Cohort B 1\. Be physically able to perform moderate exercise (to their own tolerance) on a stationary bicycle or treadmill In addition to the above patients in cohort C must meet the following criteria Inclusion Criteria: Cohort C 1. Histologically proven adenocarcinoma or poorly differentiated carcinoma 2. Patients should be chemotherapy or immune therapy naïve. 3. Patients must be able and willing to fast for 8-10 hours. 4 5.1 Patients in the anorexic group must have completed the FAACT AC/S questionnaire and scored ≤24 in total score and ≤ 2 in the appetite specific question. 5.2 For inclusion in the non-anorexic group patients must have completed the FAACT AC/S questionnaire; the total score should be \> 37 and ≥3 for the appetite specific question. Inclusion criteria: Cohort D - healthy controls 1. Participants must be 18 years of age or above. 2. Participants must be able and willing to fast for 8-10 hours. 3. Participants must be able to understand the study information given to them and be willing to give consent for trial participation. 4. Participants must have completed the FAACT AC/S questionnaire and scored ≤24 in total score and ≤ 2 in the appetite specific question, for the anorexic group. For inclusion in the non-anorexic group the total score should be \> 37 and ≥3 for the appetite specific question.
Exclusion criteria
* Participants are excluded from the study if any of the following criteria apply:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival outcomes in patients with advanced upper gastrointestinal cancers receiving dietetic interventions. | Through study completion, median expected overall survival < 1 year. | Progression free and overall survival from diagnosis. |
| Differences in patterns of plasma gut hormone and cytokine levels as measured by ELISA between study participants. | 3 months from completion of data collection | Plasma gut hormones and cytokine levels as measured via ELISA including, ghrelin, insulin, GLP-1, PYY, pancreatic polypeptide, GIP, CHromogranin A, CCK. The following cytokines will be included. IL-1, IL-6, TNF-α |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between hormonal and cytokine profile and body composition as measured by bioelectrical impedance analysis and CT measured muscle mass (for patients only) and density. | Within 6 months of completion of data collection |
| Correlation between nutritional status, body composition and physical fitness | Within 6 months of completion of data collection |
Countries
United Kingdom
Contacts
Primary ContactAlexandra Lewis
Backup ContactKate Armitage
Outcome results
None listed