Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-07-13 @ 2:45 PM
Study NCT ID:
NCT03089892
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Perspective Study of Cancer-related Fatigue in Gynecologic Cancer Patients Under Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cytokine and immune markers', 'timeFrame': 'Change from baseline cytokine and immune index at each chemotherapy cycle (each cycle is 21 or 28 days)', 'description': 'Cytokine and immune markers will be assessed from blood of cancer patients during the each chemotherapy cycle.'}], 'primaryOutcomes': [{'measure': 'Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)', 'timeFrame': 'Change from baseline cancer-related fatigue at each chemotherapy cycle (each cycle is 21 or 28 days)', 'description': 'BFI was commonly used to evaluate the cancer-related fatigue during the clinical practice.'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)', 'timeFrame': 'Change from baseline Quality of life at each chemotherapy cycle (each cycle is 21 or 28 days)', 'description': 'FACT-G7 was usually used to assess the quality of life of cancer patients during the clinical practice.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Chemotherapy is effective and most often used to treat cancer. The common drugs used on gynecologic cancer treatment include platinum compounds like cisplatin and carboplatin, which combined with taxane, topotecan, or liposomal doxorubicin to date. The most side effects of chemotherapy are esophagitis, mucositis, anxiety, nausea, vomiting, abdominal convulsion, painful swallowing, fatigue and sometimes diarrhea, dizziness, allergy (rash, itching), neutropenia, thrombocytopenia (fever, chills, cough, pain), anemia and bleeding.\n\nCancer-related fatigue (CRF), an indicator of quality of life, is a highly prevalent symptom (75-80%) during treatment and in patients with advanced cancer, yet is sometimes ignored. Fatigue affected their life more than pain. Proposed criteria for CRF have been adopted for inclusion in the International Statistical Classification of Disease and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth researches on CRF are needed in Taiwan. Patients with CRF in need of improvement, commonly use nutrition supplements, acupuncture, healthy food, massage, drugs, etc. Hence, patients with CRF could consult their vital physician for an appropriate treatment. Furthermore, several drugs could be chosen to relieve CRF, including anemia drugs, antipsychotics or Astragalus polysaccharides extract.\n\nThe objective of this retrospective study is to collect and analyze the medical records of gynecologic cancer patients who who had received chemotherapy with or without prescription drug treatment for cancer-related fatigue in the Department of Obstetrics \\& Gynecology of Tri-Service General Hospital. This study will compare the fatigue improvement profile by different chemotherapy regimens, tumor stage, CRF treatment, etc. and investigate the association between the profile of fatigue improvement and fatigue cluster (weight loss and other symptoms of functional assessment of cancer therapy). This study will also collect blood specimens and analyze the correlation of the cytokine profile and/or immune profile.These results will supply physicians with more understanding about CRF, and help them to enhance the quality on gynecologic cancer care to being perfected in the future.', 'detailedDescription': "About 60 gynecologic cancer patients' medical records are expected to collect and analyze in this retrospective study. The data collection from medical records of gynecologic cancer patients who had received chemotherapy with or without prescription drug treatment for cancer-related fatigue include the demographic information (e.g., height, weight, age, sex, tumor stage, time from tumor diagnoses, prescription drug of cancer-related fatigue treatment and chemotherapy toxicities), the diagnosis and severity of cancer-related fatigue, functional assessment of cancer therapy and so on."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gynecologic cancer patients had accepted prescription drug treatment for cancer-related fatigue under chemotherapy in the Department of Obstetrics \\& Gynecology of Tri-Service General Hospital.', 'genderDescription': 'Gynecologic cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gynecologic cancer patients under chemotherapy.\n* aged 20 and above.\n\nExclusion Criteria:\n\n* Patients who had been enrolled for other investigational drug trials within the data collection period of this study.'}, 'identificationModule': {'nctId': 'NCT03089892', 'briefTitle': 'A Perspective Study of Cancer-related Fatigue in Gynecologic Cancer Patients Under Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'A Perspective Study of Cancer-related Fatigue in Gynecologic Cancer Patients Under Chemotherapy', 'orgStudyIdInfo': {'id': 'CRF-TSGH02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gynecologic cancer patients', 'description': 'Gynecologic cancer patients under chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Cheng-Chang Chang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Division', 'investigatorFullName': 'Cheng-Chang Chang', 'investigatorAffiliation': 'China Medical University Hospital'}}}}