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
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Inclusion criteria: Cohort A

∙ Patients with stage IV gastric or GOJ adenocarcinoma or locally advanced non-resectable adenocarcinoma

‣ Histologically proven adenocarcinoma, squamous cell carcinoma or poorly differentiated carcinoma

‣ Patients should be chemotherapy or immune therapy naïve (for their current diagnosis).

‣ Patient must be 18 years of age or above.

‣ Patient must be able to understand the study information given to them and be willing to give consent for trial participation.

‣ 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

• 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

⁃ Histologically proven adenocarcinoma or poorly differentiated carcinoma

⁃ Patients should be chemotherapy or immune therapy naïve.

⁃ 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.

• 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.

⁃ Participants must be 18 years of age or above.

⁃ Participants must be able and willing to fast for 8-10 hours.

⁃ Participants must be able to understand the study information given to them and be willing to give consent for trial participation.

⁃ 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.

Locations
Other Locations
United Kingdom
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Alexandra Lewis
alexandra.lewis12@nhs.net
+44 161 918 7887
Backup
Kate Armitage
kate.armitage3@nhs.net
+44 161 918 7887
Time Frame
Start Date: 2021-07-15
Estimated Completion Date: 2026-04
Participants
Target number of participants: 450
Treatments
A - main study cohort
This is the main study cohort. All patients with upper gastrointestinal (gastric, oesophageal and gastro-oesophageal) cancers attending the medical oncology clinic and commencing systemic therapy will be invited to participate.~They will receive dietician support as part of their standard treatment. They will undergo assessments of body composition as part of this assessment
Sub-cohort B
This sub-cohort will be invited to undergo more detailed fitness testing in the form of cardio-pulmonary exercise testing in addition to their routine care in the main cohort
sub-cohort C
This sub-cohort will be invited to undergo an assessment of gut hormone and cytokine levels in addition to their routine care in the main cohort
Cohort D
This is a cohort of healthy volunteers invited to act as a control to cohort C and undergo the gut hormone assessment
Related Therapeutic Areas
Sponsors
Collaborators: Manchester Metropolitan University, University of Manchester
Leads: The Christie NHS Foundation Trust

This content was sourced from clinicaltrials.gov