Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 6:14 AM
Study NCT ID:
NCT04871204
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2021-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D013272', 'term': 'Stomach 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change in percent (%)', 'timeFrame': 'From baseline before surgery, at 1, 2, 3, and 6 months', 'description': 'Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Changes in gastrointestinal satiety hormone levels', 'timeFrame': 'Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months', 'description': 'Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days post-surgery and after 1, 2, 3 and 6 months.'}, {'measure': 'Changes in body composition', 'timeFrame': 'Baseline, 1, 2, 3, and 6 months', 'description': 'Body composition measured in percent (%) body fat (continuously)'}, {'measure': 'Changes in nutritional status - PG-SGA', 'timeFrame': 'Baseline, 1, 2, 3, and 6 months', 'description': 'Nutritional status measured with the questionnaire PG-SGA'}, {'measure': 'Changes in nutritional status - EORTC CAX24', 'timeFrame': 'Baseline, 1, 2, 3, and 6 months', 'description': 'Nutritional status measured with the questionnaire EORTC CAX24'}, {'measure': 'Health-related Quality of Life - EORTC QLQ-C30', 'timeFrame': 'Baseline, 1, 2, 3 and 6 months', 'description': 'Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 at baseline and at 1, 2, 3 and 6 months after randomization'}, {'measure': 'Health-related Quality of Life - QLQ-OG25', 'timeFrame': 'Baseline, 1, 2, 3 and 6 months', 'description': 'Health-related Quality of Life (HRQOL) measured using QLQ-OG25 at baseline and at 1, 2, 3 and 6 months after randomization'}, {'measure': 'Percentage (of subjects) in need of enteral nutrition', 'timeFrame': 'Baseline, 1, 2, 3 and 6 months', 'description': 'Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube'}, {'measure': 'Number and type of Adverse Events', 'timeFrame': 'From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously)', 'description': 'Number and type of Adverse Events, including known AEs of Sandostatin LAR depot'}, {'measure': 'Number of patients completing treatment', 'timeFrame': 'From first treatment at 7 days post-surgery to last treatment at 2 months', 'description': 'Number of patients completing treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight loss', 'Quality of Life', 'Nutritional recovery'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to clarify whether octreotide therapy can reduce undesired postoperative weight loss, increase health-related quality of life and improve the appetite after surgery for esophageal or gastric cancer.', 'detailedDescription': 'Dietary complications are the biggest problem for patients before, during and after surgical treatment. Improved multimodal therapy and centralization of treatment to highly specialized centers have led to an increase in the number of patients surviving with chronic negative effects of esophageal surgery. The scientific state of knowledge about HRQOL and the symptoms of long-term survival of esophageal cancer is limited.\n\nPatient-reported outcome measures (PRUs) are results reported by the patient himself, e.g. HRQOL, remaining symptoms, satisfaction with health care and other problems in daily life. These results have rarely been of importance before but are now increasingly crucial in the evaluation of treatment. It is no longer just about survival for patients with cancer of the esophagus. The aim of the study is to clarify whether octreotide therapy can reduce undesired postoperative weight loss, increase health-related quality of life and improve the appetite after surgery for esophageal or gastric cancer.\n\nOur hypothesis is that intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer and that it may improve postoperative health related quality of life. This study aims to investigate if postoperative eating problems can be reduced by treatment with octreotide in this patient group.\n\nIn the first part of the study: Sub study 1, safety, tolerability and feasibility of octreotide treatment will be investigated. Twenty patients diagnosed with esophageal or gastric cancer will receive three monthly injections of 10 mg of Sandostatin LAR depot. Patients will be followed up at 1, 2, 3 and 6 months for monitoring of safety blood parameters, changes in weight, health-related quality of life and adverse events.\n\nIn the second part of the study: Sub study 2, efficacy of treatment with octreotide will be studied. 152 patients diagnosed with esophageal or gastric cancer will be randomized 1:1 to post-surgical treatment with octreotide or no treatment. Patients in the active arm will receive three monthly injections of 10 mg of Sandostatin LAR depot. All patients will be followed up at 1, 2, 3 and 6 months in the same manner as in Sub study 1. In this study part gastrointestinal satiety hormones and nutritional evaluation associated quality of life will be studied in addition to body weight, body composition and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer\n2. Gastrectomy or esophagectomy with curative intent\n3. ≥18 years of age\n4. Signed informed consent\n5. Able to comply with the procedures of the study protocol, in the opinion of the investigator\n6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study.\n\nExclusion Criteria:\n\n1. Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery\n2. Complications leading to restrictions in postoperative oral intake\n3. Advanced comorbidity with ASA score III or more\n4. Bradycardia (defined as resting heart rate of under 60 beats per minute)\n5. Chronic obstructive pulmonary disease\n6. Chronic liver disease\n7. Insulinoma\n8. Kidney failure\n9. Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine\n10. Known or suspected allergy to octreotide\n11. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation\n12. Pregnant or nursing female\n13. Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT04871204', 'acronym': 'OTIS', 'briefTitle': 'Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS', 'orgStudyIdInfo': {'id': 'OTIS2019_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Octreotide', 'description': '3 monthly intramuscular injections of 10 mg Octreotide', 'interventionNames': ['Drug: Octreotide Injection']}], 'interventions': [{'name': 'Octreotide Injection', 'type': 'DRUG', 'description': '10 mg Sandostatin LAR intramuscular injection', 'armGroupLabels': ['Octreotide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Fredrik Klevebro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fredrik Klevebro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fredrik Klevebro', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}