Investigating nutrition and appetite in cancer patients

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)

This study is testing how nutrition affects appetite and overall health in people with advanced stomach and esophagus cancers to see if it can help improve their well-being.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Christie NHS Foundation Trust (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Manchester)
• Trial ID: NCT04791254 on ClinicalTrials.gov

What this trial studies

This study aims to prospectively examine the outcomes of patients with advanced gastrointestinal cancers, specifically gastric and oesophageal cancers, who are undergoing standard dietetic interventions. It will explore the relationship between nutritional status, body composition, and fitness, as well as the impact of pro-inflammatory cytokines on appetite regulation. Additionally, a sub-study will investigate the neuronal-enteroendocrine-hypothalamic axis to better understand its role in appetite impairment among these patients. The study will compare levels of gut hormones and cytokines between anorexic and non-anorexic cancer patients and healthy controls.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and above with stage IV gastric or gastro-oesophageal junction adenocarcinoma who are chemotherapy or immune therapy naïve.

Not a fit: Patients with early-stage cancers or those who are not undergoing palliative chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional interventions that enhance treatment outcomes and quality of life for patients with advanced gastrointestinal cancers.

How similar studies have performed: While the specific approach of this study is novel, similar studies have indicated that addressing nutritional status can significantly impact outcomes in cancer patients.

Eligibility criteria

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:

Exclusion criteria Cohort A:

1. Patients unable to give informed consent
2. 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.

Exclusion criteria Cohort B:

1. Recent myocardial infarction or stroke
2. Recent abdominal, eye or thoracic surgery
3. A recent respiratory tract infection (within 3 weeks)
4. Any chest pain on the day of the test
5. A positive COVID-19 test

Exclusion Criteria Cohort C \& D : all patients and healthy volunteers

1. 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.
2. Presence of oesophageal stent or any other kind of feeding aid (nasogastric tube, nasoduodenal tube, gastrostomy, jejunostomy)
3. Presence of brain metastases or any kind of brain tumor including benign pituitary adenomas.
4. Histological diagnosis of neuroendocrine tumor, or mixed tumor.
5. Previous gastro-duodenal surgery.
6. History of Inflammatory Bowel Disease (Ulcerative colitis, Crohn's disease).
7. History of Coeliac disease.
8. History of endocrine disease (Diabetes mellitus, Thyroid disease, Cushing's)
9. Significant past or present eating disorder e.g. anorexia nervosa, bulimia nervosa.
10. Current active infection (general or intestinal).
11. Chronic use of immunomodulatory drugs (steroids, immunosuppressant drugs, recent use of corticosteroids would require a two week washout period prior to study assessments).
12. Chronic use of NSAIDS or aspirin. (Periodic use can be accepted).
13. Patients with pacemakers. (Contraindication for BIA).
14. Allergy to any of the ingredients of the meal test or unwillingness to consume the particular meal (Heinz Chicken soup or Heinz Mushroom soup).

Where this trial is running

Manchester

• The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Was Mansoor — The Christie NHS Foundation Trust
• Study coordinator: Alexandra Lewis

Conditions Gastric Cancer; Oesophageal Cancer