Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT03773003
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study."}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded, placebo controlled intervention with probiotics\n\nThere are three groups in the study:\n\n1. Tumor disease with fatigue\n2. Tumor disease without fatigue\n3. Healthy control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of fatigue symptoms', 'timeFrame': '3 months after end of chemotherapy', 'description': 'Improvement of fatigue as measured by validated psychometric questionnaires.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Fatigue, Chronic Fatigue'], 'conditions': ['Cancer Related Fatigue', 'Fatigue Syndrome, Chronic']}, 'descriptionModule': {'briefSummary': 'Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.', 'detailedDescription': 'This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease with and without fatigue. These results will be compared to an age- and gender matched control group with a comparable tumor disease and to another age- and gender matched control group without tumor disease.\n\nThe investigators are following the same strategy for investigating an underlying pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age- and gender matched control group will be established from the beforementioned control group.\n\nThe investigators will also be screening for a peritoneal microbiome (possible correlate for leaky gut) in study patients undergoing abdominal surgery.\n\nWe will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome by double-blinded, placebo-controlled administration of probiotics to the study population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically, cytologically or radiologically confirmed tumor disease\n* indication for chemotherapy\n* Written consent to participation\n\nExclusion Criteria:\n\n* chronic-inflammatory bowel disease\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03773003', 'acronym': 'IMPROFA', 'briefTitle': 'Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) by Lipidomics, Metabolomics, Microbiome and Exome Analysis and Investigation of Clinical Improvement Under Administration of Probiotics', 'orgStudyIdInfo': {'id': 'IMPROFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Tumor disease w/o fatigue', 'description': 'Group receiving probiotics.', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Tumor disease w/o fatigue', 'description': 'Group receiving placebo (corn starch)', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3: Healthy control group', 'description': 'Group receiving probiotics', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4: Healthy control group', 'description': 'Group receiving placebo (corn starch)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The administered probiotics are readily available on the market and contain\n\n* Bifidobacterium breve, B. infantis, B. lactis, B. longum\n* Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius\n* Streptococcus thermophilus', 'armGroupLabels': ['Arm 1: Tumor disease w/o fatigue', 'Arm 3: Healthy control group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Identically looking to verum, containing corn starch.', 'armGroupLabels': ['Arm 2: Tumor disease w/o fatigue', 'Arm 4: Healthy control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66424', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Jelden, Dr.', 'role': 'CONTACT', 'email': 'michael.jelden@uks.eu', 'phone': '+49684116', 'phoneExt': '30000'}, {'name': 'Michael Jelden, Dr.', 'role': 'CONTACT', 'email': 'michael.jelden@uks.eu', 'phone': '49684116', 'phoneExt': '15000'}, {'name': 'Michael Jelden, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saarland University Medical Center', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'centralContacts': [{'name': 'Michael Jelden, MD', 'role': 'CONTACT', 'email': 'michael.jelden@uks.eu', 'phone': '+4968411630000'}], 'overallOfficials': [{'name': 'Michael Jelden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Saarland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Jelden', 'investigatorAffiliation': 'University Hospital, Saarland'}}}}