Anorexia iN Cancer Patients: ANCHOR

NCT04791254 | Recruiting DMC

• 1 other identifier: CFTSp141
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Oesophageal Cancer

Outcome Measures

Primary Outcomes (2)

• Survival outcomes in patients with advanced upper gastrointestinal cancers receiving dietetic interventions.

  Progression free and overall survival from diagnosis.

  Through study completion, median expected overall survival < 1 year.

• Differences in patterns of plasma gut hormone and cytokine levels as measured by ELISA between study participants.

  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

  3 months from completion of data collection

Secondary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced (either metastatic, or locally advanced and inoperable) gastro-oesophgeal (including primary oesophageal, gastro-oesophageal junction or gastric) cancer, presenting to undergo first line systemic therapy

You may qualify if:

• 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
• \. 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.
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Patients unable to give informed consent
• Patients not undergoing systemic anti-cancer treatment at The Christie hospital, for example patients not deemed fit enough for treatment, patients having alternative treatments such as radiotherapy or surgery, or patients referred for 2nd opinions.
• Recent myocardial infarction or stroke
• Recent abdominal, eye or thoracic surgery
• A recent respiratory tract infection (within 3 weeks)
• Any chest pain on the day of the test
• A positive COVID-19 test
• Symptoms of dysphagia of any cause, oesophageal or gastric obstruction (assessed via medical history/O'Rourke score). Patients with O'Rourke score ≥2 will be excluded.
• Presence of oesophageal stent or any other kind of feeding aid (nasogastric tube, nasoduodenal tube, gastrostomy, jejunostomy)
• Presence of brain metastases or any kind of brain tumor including benign pituitary adenomas.
• Histological diagnosis of neuroendocrine tumor, or mixed tumor.
• Previous gastro-duodenal surgery.
• History of Inflammatory Bowel Disease (Ulcerative colitis, Crohn's disease).
• History of Coeliac disease.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Manchester: collaborator
• Manchester Metropolitan University: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Was Mansoor

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Lewis

CONTACT

+44 161 918 7887; alexandra.lewis12@nhs.net

Kate Armitage

CONTACT

+44 161 918 7887; kate.armitage3@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 10, 2021
• Study Start: July 15, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)