Esophageal CancerREWARDNCT03377660
Resection of the Esophagus and Subsequent Weight Loss
An observational study of Esophageal Cancer and Weight Gain, run by Imperial College London at 1 site in Ireland.
Trial summary
The investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Weight Gain, Eating Behavior
- What is being tested?
- Clinical treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2018to 1 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of post-esophagectomy patients at least 1 year after curative surgery, but struggling with unintentional weight loss of at least 10% baseline body weight, and thus candidates for clinical treatment.
Who may be able to join
- History of esophagectomy with gastric conduit reconstruction
- Recurrence-free at least 12 months post-operatively
- Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation
- Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine
Who cannot join
- Pregnancy, breastfeeding
- Significant and persistent chemoradiotherapy and/or surgical complication
- Other active malignancy
- Exocrine pancreatic insufficiency detected using fecal elastase
- Uncontrolled diabetes mellitus
- Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
Show all 12Show fewer
- Severe dysphagia
- Other disease or medication which may impact gut hormone physiology
- History of significant food allergy, certain dietary restrictions
- Any definite contraindication to somatostatin analogue administration
- Claustrophobia, or any absolute contraindication to MRI scanning
- Metallic implants, precluding fMRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer
The investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating behaviour), how these differ in response to multiple clinical treatment options, as well as how they relate to weight gain while on treatment.
Read the detailed description
The incidence of cancer of the oesophagus (food pipe) is increasing. Improvements in treatment strategies have resulted in more people who remain free from cancer recurrence in the long term following treatment.
Surgery is the cornerstone of treatment for patients with oesophageal cancer, but while surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Poor appetite, weight loss and nutritional impairment are common problems among patients who attain long-term cancer remission and cure after surgery.
A new clinic has been established to treat patients who are in remission but who have lost more than 10% of their body weight secondary to the effects of the surgery and struggling to regain weight. These patients will be treated as per standard of care with medications to aid weight gain.
The investigators are interested to conduct research into how the reward value of food changes during the clinical treatment pathway. The hypothesis is that there will be an increased reward response to food after medication use, the magnitude of which will correlate with weight gain. To assess this, patients who are already part of this clinic will be approached to have fMRI that can demonstrate changes in brain reward centres as well as a Progressive Ratio Task, which is a direct measure of appetitive behaviour. Changes in brain reward centre responses and appetitive behaviour will be correlated with changes in weight after pharmacotherapy. This may further inform future clinical protocols to provide improved precision medicine.
- Conditions
- Esophageal Cancer, Weight Gain, Eating Behavior, Food Reward
- Being tested
- Clinical treatment
- Keywords
- Esophagectomy, Unintentional weight loss, Gut hormones
- Medical subject headings
- Esophageal Neoplasms, Weight Gain, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical treatmentOther
Patients undergo clinical treatment as indicated, they are studied before and after.
| Study group | Role | What they receive |
|---|---|---|
| Sandostatin | This cohort will be the group who are undergoing routine clinical treatment with a long-acting somatostatin analogue to minimise abnormal gut hormone signalling, and thus reduce early satiety. Receives: Other: Clinical treatment | |
| Mirtazapine | This cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite. Receives: Other: Clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOLD signal
Measure of food reward on fMRI
Measured: Before and after 4 weeks of clinical treatment
Change in breakpoint at PRT
Measure of drive to eat
Measured: Before and after 4 weeks of clinical treatment
Secondary outcomes (2)
Correlation of weight change during treatment with BOLD signal changes
Relationship of food reward changes to weight gain
Measured: Before and after 4 weeks of clinical treatment
Correlation of weight change during treatment with PRT breakpoint changes
Relationship of eating behaviour changes to weight gain
Measured: Before and after 4 weeks of clinical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Why it stopped: Funding stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Carel Le Roux, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377660
- Sponsor's protocol ID
- CRFSJ0148
- Acronym
- REWARD
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2017
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT03377660
- Acronym / sponsor ID
- REWARD / CRFSJ0148
- Conditions
- Esophageal Cancer, Weight Gain, Eating Behavior, Food Reward
- Keywords
- Esophagectomy, Unintentional weight loss, Gut hormones
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding stopped.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University College Dublin, St. James's Hospital, Ireland
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Dec 2017 (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 investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating behaviour), how these differ in response to multiple clinical treatment options, as well as how they relate to weight gain while on treatment.
Detailed description
The incidence of cancer of the oesophagus (food pipe) is increasing. Improvements in treatment strategies have resulted in more people who remain free from cancer recurrence in the long term following treatment.
Surgery is the cornerstone of treatment for patients with oesophageal cancer, but while surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Poor appetite, weight loss and nutritional impairment are common problems among patients who attain long-term cancer remission and cure after surgery.
A new clinic has been established to treat patients who are in remission but who have lost more than 10% of their body weight secondary to the effects of the surgery and struggling to regain weight. These patients will be treated as per standard of care with medications to aid weight gain.
The investigators are interested to conduct research into how the reward value of food changes during the clinical treatment pathway. The hypothesis is that there will be an increased reward response to food after medication use, the magnitude of which will correlate with weight gain. To assess this, patients who are already part of this clinic will be approached to have fMRI that can demonstrate changes in brain reward centres as well as a Progressive Ratio Task, which is a direct measure of appetitive behaviour. Changes in brain reward centre responses and appetitive behaviour will be correlated with changes in weight after pharmacotherapy. This may further inform future clinical protocols to provide improved precision medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sandostatin | – | Other: Clinical treatmentThis cohort will be the group who are undergoing routine clinical treatment with a long-acting somatostatin analogue to minimise abnormal gut hormone signalling, and thus reduce early satiety. |
| Mirtazapine | – | Other: Clinical treatmentThis cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of post-esophagectomy patients at least 1 year after curative surgery, but struggling with unintentional weight loss of at least 10% baseline body weight, and thus candidates for clinical treatment.
Key inclusion criteria (4 listed)
- History of esophagectomy with gastric conduit reconstruction
- Recurrence-free at least 12 months post-operatively
- Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation
- Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine
Key exclusion criteria (12 listed)
- Pregnancy, breastfeeding
- Significant and persistent chemoradiotherapy and/or surgical complication
- Other active malignancy
- Exocrine pancreatic insufficiency detected using fecal elastase
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical treatmentPatients undergo clinical treatment as indicated, they are studied before and after. | Other | Mirtazapine, Sandostatin |
Primary outcome
Change in BOLD signal
Time frame: Before and after 4 weeks of clinical treatment
Measure of food reward on fMRI
Change in breakpoint at PRT
Time frame: Before and after 4 weeks of clinical treatment
Measure of drive to eat
2 secondary outcomes
Correlation of weight change during treatment with BOLD signal changes
Time frame: Before and after 4 weeks of clinical treatment
Correlation of weight change during treatment with PRT breakpoint changes
Time frame: Before and after 4 weeks of clinical treatment
Results and safety
The study was stopped early (reason given: Funding stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esophageal Cancer and Weight Gain, run by Imperial College London at 1 site in Ireland.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 27 Mar 2024. 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 Ireland. 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?
The study was stopped early (reason given: Funding stopped.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BOLD signal (time frame: Before and after 4 weeks of clinical treatment). 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 27 Mar 2024.