Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:02 AM
Study NCT ID:
NCT07443618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Fluid Buildup in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood, plasma and urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bio Impedance: ΔTotal body fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) and ΔPhase angle PhA (°)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Electrodes placed on hands/writs and feet/lower shins'}], 'secondaryOutcomes': [{'measure': 'Bio Impedance: ΔSegmental fluid volume (kg) including ΔResistance R (Ω), ΔReactance Xc (Ω) og ΔPhase angle PhA (°)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Electrodes placed close to the local oedema'}, {'measure': 'ΔBody weight (kg)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.'}, {'measure': 'ΔdU-urea (mmol/d)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on 24 h urine collection'}, {'measure': 'ΔdU-creatinine (mmol/d)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on 24 h urine collection'}, {'measure': 'ΔdU-sodium (mmol/d)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on 24 h urine collection'}, {'measure': 'ΔdU-potassium (mmol/d)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on 24 h urine collection'}, {'measure': 'ΔdU-chloride (mmol/d)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on 24 h urine collection'}, {'measure': 'ΔdU-pH', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on spot urine'}, {'measure': 'ΔEnergy intake (kJ/kg/day)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Both oral, enteral and parenteral.'}, {'measure': 'ΔProtein intake (g/kg/day)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Both oral, enteral and parenteral.'}, {'measure': 'ΔSodium intake (mg/kg/day)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Both oral, enteral and parenteral.'}, {'measure': 'ΔPotassium intake (mg/kg/day)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Both oral, enteral and parenteral.'}, {'measure': 'ΔChloride intake (mg/kg/day)', 'timeFrame': 'Measurement days 1, 3, and 5. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Both oral, enteral and parenteral'}, {'measure': 'ΔPlasma colloid osmotic pressure (mmHg)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔPlasma albumin (g/L)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔBlood haemoglobin (g/L)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔPlasma creatinine (micromoles per liter)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔPlasma urea (mmol/L)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔPlasma glucose (mmol/L)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔBlood haematocrit (%)', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔPlasma CRP', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'ΔBlood leucocytes', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.', 'description': 'Based on blood sample'}, {'measure': 'Clinical palpatory assessment of oedema volume', 'timeFrame': 'Measurement days 2, 4, and 6. For outpatients: measurement days 1+2, 3+4, and 5+6 are separated by a 7-14-day interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Localized oedema in cancer', 'Bioelectrical impedance', 'Post radiation lymphoedema'], 'conditions': ['Cancer', 'Oedema', 'Bioelectrical Impedance', 'Lymphoedema', 'Chemotherapy', 'Radiotherapy', 'Fluid Balance']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to improve the monitoring of fluid retention in cancer patients. The main question it aims to answer is: Can segmental bioelectrical impedance analysis be used to monitor local fluid retention (edema) in cancer patients? We will include:\n\n* Breast cancer patients with fluid and or lymph retention in one or both arms after radiotherapy (outpatients)\n* Cancer patients with fluid retention in one or both legs after chemotherapy (hospitalized)\n\nParticipants will:\n\n* Have measurements taken using bioelectrical impedance\n* Provide blood samples and 24-hour urine collection\n* Weight monitorering\n* Complete diet and fluid registration (inclusive enteral and parenteral)\n* Have clinical palpatory and measurement assessment of oedema.', 'detailedDescription': 'Both groups will undergo measurements over a maximum period of six days.\n\nOutpatients:\n\nOutpatients will complete three measurement cycles, each consisting of two consecutive days:\n\n* Day 1: Home-based dietary and fluid intake registration and 24-h urine collection\n* Day 2: Hospital-based assessment including bioelectrical impedance analysis (BIA), blood sampling, body weight measurement, and clinical palpatory assessment\n\nEach measurement cycle will be separated by a 7-14-day interval.\n\nHospitalized patients:\n\nHospitalized patients will undergo up to six consecutive measurement days, or until discharge or transfer to another ward:\n\n* Days 1, 3, and 5: Dietary and fluid intake registration and 24-h urine collection\n* Days 2, 4, and 6: Bioelectrical impedance analysis (BIA), blood sampling, body weight measurement, and clinical palpatory assessment\n\nIf the treating physician administers i.v. loop diuretics to the hospitalized patient, additional measurements will be taken before administration and hourly for five hours thereafter, as these may significantly affect fluid levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population consists of patients recruited from Aalborg University Hospital at the Department of Oncology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Outpatient breast cancer patients with lymphoedema after radiotherapy):\n\n* Habile\n* Must be able to speak and read Danish\n* Has received/is receiving radiotherapy due to breast cancer within the last 6 months\n* Is being followed in the Oncology Outpatient Clinic at Aalborg University Hospital\n* Age ≥ 18 years\n* Visible lymphoedema in at least one upper extremity\n\nInclusion Criteria (Hospitalized cancer patients with peripheral oedema in one or both lower extremities after chemotherapy):\n\n* Habile\n* Must be able to speak and read Danish\n* Has received/is receiving chemotherapy due to cancer within the last 2 months\n* Hospitalised in the Oncology Ward at Aalborg University Hospital\n* Estimated length of hospital stay of at least 6 days\n* Age ≥ 18 years\n* Visible peripheral oedema in at least one lower extremity\n\nExclusion Criteria (both groups):\n\n* Pregnant or breastfeeding women\n* Amputated limb(s)\n* Pacemaker or implanted cardioverter-defibrillator due to risk of interference from the electrical signal\n* Metallic prostheses due to risk of interference with the device signal\n* Inability to lie still for the duration of the measurement interval (minimum 2 minutes at a time)\n* Inability to stand on a scale, i.e. permanently bedridden.\n* Inability to cooperate with urine collection\n* Receiving dialysis\n* Terminal illness'}, 'identificationModule': {'nctId': 'NCT07443618', 'briefTitle': 'Measuring Fluid Buildup in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Monitoring of Oedema in Cancer Patients - A Pilot Study', 'orgStudyIdInfo': {'id': 'N-20250028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatient breastcancer patients with lymphoedema in arm/arms after radiotherapy'}, {'label': 'Hospitalized cancer patients with oedema in leg/legs after chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'state': 'The North Denmark Region', 'country': 'Denmark', 'contacts': [{'name': 'Emilie S Nør', 'role': 'CONTACT', 'email': 'e.noer@rn.dk', 'phone': '004520232289'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Emilie S Nør, Clinical Dietitian, Stud.MSc', 'role': 'CONTACT', 'email': 'e.noer@rn.dk', 'phone': '004520232289'}, {'name': 'Jens R Andersen, MD, MPA', 'role': 'CONTACT', 'email': 'jra@nexs.ku.dk', 'phone': '0045 23346654'}], 'overallOfficials': [{'name': 'Jens R Andersen, MD, MPA, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared because the data are personal and sensitive.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Emeritus', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}