Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 11:23 AM
Study NCT ID:
NCT03377660
Status:
TERMINATED
Last Update Posted:
2024-03-27
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resection of the Esophagus and Subsequent Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding stopped.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BOLD signal', 'timeFrame': 'Before and after 4 weeks of clinical treatment', 'description': 'Measure of food reward on fMRI'}, {'measure': 'Change in breakpoint at PRT', 'timeFrame': 'Before and after 4 weeks of clinical treatment', 'description': 'Measure of drive to eat'}], 'secondaryOutcomes': [{'measure': 'Correlation of weight change during treatment with BOLD signal changes', 'timeFrame': 'Before and after 4 weeks of clinical treatment', 'description': 'Relationship of food reward changes to weight gain'}, {'measure': 'Correlation of weight change during treatment with PRT breakpoint changes', 'timeFrame': 'Before and after 4 weeks of clinical treatment', 'description': 'Relationship of eating behaviour changes to weight gain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophagectomy', 'Unintentional weight loss', 'Gut hormones'], 'conditions': ['Esophageal Cancer', 'Weight Gain', 'Eating Behavior', 'Food Reward']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSurgery 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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of esophagectomy with gastric conduit reconstruction\n2. Recurrence-free at least 12 months post-operatively\n3. Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation\n4. Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine\n\nExclusion Criteria:\n\n1. Pregnancy, breastfeeding\n2. Significant and persistent chemoradiotherapy and/or surgical complication\n3. Other active malignancy\n4. Exocrine pancreatic insufficiency detected using fecal elastase\n5. Uncontrolled diabetes mellitus\n6. Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent\n7. Severe dysphagia\n8. Other disease or medication which may impact gut hormone physiology\n9. History of significant food allergy, certain dietary restrictions\n10. Any definite contraindication to somatostatin analogue administration\n11. Claustrophobia, or any absolute contraindication to MRI scanning\n12. Metallic implants, precluding fMRI'}, 'identificationModule': {'nctId': 'NCT03377660', 'acronym': 'REWARD', 'briefTitle': 'Resection of the Esophagus and Subsequent Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CRFSJ0148'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sandostatin', 'description': '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.', 'interventionNames': ['Other: Clinical treatment']}, {'label': 'Mirtazapine', 'description': 'This cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite.', 'interventionNames': ['Other: Clinical treatment']}], 'interventions': [{'name': 'Clinical treatment', 'type': 'OTHER', 'description': 'Patients undergo clinical treatment as indicated, they are studied before and after.', 'armGroupLabels': ['Mirtazapine', 'Sandostatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': 'Conway Institute, UCD', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}, {'name': "St. James's Hospital, Ireland", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of experimental pathology, Reader in investigative science', 'investigatorFullName': 'Carel Le Roux', 'investigatorAffiliation': 'Imperial College London'}}}}