Gastric CancerANCHORNCT04791254
Anorexia iN Cancer Patients: ANCHOR
An observational study of Gastric Cancer and Oesophageal Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Oesophageal Cancer
- How many people
- 450 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2021to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
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- 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.
- 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.
- 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.
Who cannot join
- 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)
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- Any chest pain on the day of the test
- A positive COVID-19 test
- Exclusion Criteria Cohort C \& D : all patients and healthy volunteers
- 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.
- History of endocrine disease (Diabetes mellitus, Thyroid disease, Cushing's)
- Significant past or present eating disorder e.g. anorexia nervosa, bulimia nervosa.
- Current active infection (general or intestinal).
- Chronic use of immunomodulatory drugs (steroids, immunosuppressant drugs, recent use of corticosteroids would require a two week washout period prior to study assessments).
- Chronic use of NSAIDS or aspirin. (Periodic use can be accepted).
- Patients with pacemakers. (Contraindication for BIA).
- Allergy to any of the ingredients of the meal test or unwillingness to consume the particular meal (Heinz Chicken soup or Heinz Mushroom soup).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Kate Armitage, +44 161 918 7887, kate.armitage3@nhs.net
Alexandra Lewis
About this study
Official title: 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)
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.
Read more
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.
Read the 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
- Gastric Cancer, Oesophageal Cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival outcomes in patients with advanced upper gastrointestinal cancers receiving dietetic interventions.
Progression free and overall survival from diagnosis.
Measured: 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
Measured: 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.
Measured: Within 6 months of completion of data collection
Correlation between nutritional status, body composition and physical fitness
Measured: Within 6 months of completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Jul 2021
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Was Mansoor, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791254
- Sponsor's protocol ID
- CFTSp141
- Acronym
- ANCHOR
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04791254
- Acronym / sponsor ID
- ANCHOR / CFTSp141
- Conditions
- Gastric Cancer, Oesophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester, Manchester Metropolitan University
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival outcomes in patients with advanced upper gastrointestinal cancers receiving dietetic interventions.
Time frame: 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.
Time frame: 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
2 secondary outcomes
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.
Time frame: Within 6 months of completion of data collection
Correlation between nutritional status, body composition and physical fitness
Time frame: Within 6 months of completion of data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Was Mansoor principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Oesophageal Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Lewis (+44 161 918 7887, alexandra.lewis12@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival outcomes in patients with advanced upper gastrointestinal cancers receiving dietetic interventions. (time frame: Through study completion, median expected overall survival < 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.