Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 8:20 AM
Study NCT ID:
NCT04692168
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2020-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Chemotherapy on Postural Control in Women With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline : postural control under various conditions.', 'timeFrame': 'Prior and three months after chemotherapy', 'description': 'The postural control will be assessed by a force platform. Three 30-second tests will be performed for each test condition. The test conditions are as follows: eyes open, eyes closed, firm surface, soft surface, with vibrator, without vibrator, with dual task. The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a point on the wall at 0.90 cm. Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline : modifications of postural control according to the conditions tested.', 'timeFrame': 'Prior and three months after chemotherapy', 'description': 'The postural control will be assessed by a force platform. Three 30-second tests will be performed for each test condition. The test conditions are as follows: eyes open, eyes closed, firm surface, soft surface, with vibrator, without vibrator, with dual task. The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a point on the wall at 0.90 cm. Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.'}, {'measure': 'Change from baseline : standing dynamic stability.', 'timeFrame': 'Prior and three months after chemotherapy', 'description': 'The standing dynamic stability will be assessed by a force platform with the limits of stability test (LOS). The test position will be standing with the feet 10 cm apart at heel level and 15 cm apart at hallux level, with the arms along the body, fixing a computer at a distance of 0.90 cm. Parameters of center of pressure and strength will be recorded at a frequency of 100 Hertz.'}, {'measure': 'Change from baseline : quality of life assessed by the questionnaire Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX).', 'timeFrame': 'Prior and three months after chemotherapy', 'description': 'The FACT/GOG-NTX was chosen to assess the quality of life (QoL). This questionnaire assesses physical well-being, family/social well-being, emotional well-being, functional well-being and other concern. Participants will have to answer the different statements by ticking the box corresponding to what they feel is adequate between 0 (not at all) and 4 (a lot). The minimum score is 0 and the maximum score is 152. The higher the score, the better the QoL.'}, {'measure': 'Change from baseline : investigate the association between the severity of CIPN (mild, moderate, severe) and the postural control, dynamic balance and QoL of individuals with gynaecological cancer.', 'timeFrame': 'Prior and three months after chemotherapy', 'description': 'The clinical version of the Total Neuropathy Score will be used to evaluate the presence of peripheral neuropathy. A test of superficial sensitivity, vibration sensitivity, reflexes and strength will be carried out. The minimum score is 0 and the maximum score is 24. A score between 0 and 8 indicates mild peripheral neuropathy, between 9 and 16 a moderate peripheral neuropathy and above 17 a severe neuropathy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postural control', 'balance', 'chemotherapy induced peripheral neuropathy', 'quality of life'], 'conditions': ['Cancer, Breast', 'Cancer, Gynecologic']}, 'referencesModule': {'references': [{'pmid': '26350407', 'type': 'BACKGROUND', 'citation': 'Kneis S, Wehrle A, Freyler K, Lehmann K, Rudolphi B, Hildenbrand B, Bartsch HH, Bertz H, Gollhofer A, Ritzmann R. Balance impairments and neuromuscular changes in breast cancer patients with chemotherapy-induced peripheral neuropathy. Clin Neurophysiol. 2016 Feb;127(2):1481-1490. doi: 10.1016/j.clinph.2015.07.022. Epub 2015 Aug 14.'}, {'pmid': '31390588', 'type': 'BACKGROUND', 'citation': "McCrary JM, Goldstein D, Trinh T, Timmins HC, Li T, Menant J, Friedlander M, Lewis CR, Hertzberg M, O'Neill S, King T, Bosco A, Harrison M, Park SB. Balance Deficits and Functional Disability in Cancer Survivors Exposed to Neurotoxic Cancer Treatments. J Natl Compr Canc Netw. 2019 Aug 1;17(8):949-955. doi: 10.6004/jnccn.2019.7290."}, {'pmid': '30741022', 'type': 'BACKGROUND', 'citation': 'Monfort SM, Pan X, Loprinzi CL, Lustberg MB, Chaudhari AMW. Impaired Postural Control and Altered Sensory Organization During Quiet Stance Following Neurotoxic Chemotherapy: A Preliminary Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419828823. doi: 10.1177/1534735419828823.'}, {'pmid': '32036320', 'type': 'BACKGROUND', 'citation': 'Muller J, Ringhof S, Vollmer M, Jager LB, Stein T, Weiler M, Wiskemann J. Out of balance - Postural control in cancer patients before and after neurotoxic chemotherapy. Gait Posture. 2020 Mar;77:156-163. doi: 10.1016/j.gaitpost.2020.01.012. Epub 2020 Jan 15.'}, {'pmid': '40448057', 'type': 'DERIVED', 'citation': 'Reinmann A, Bodmer A, Koessler T, Gligorov J, Bruyneel AV. Postural control impairments following neurotoxic chemotherapy in women with cancer: a prospective observational study. BMC Womens Health. 2025 May 30;25(1):269. doi: 10.1186/s12905-025-03790-4.'}, {'pmid': '36691184', 'type': 'DERIVED', 'citation': 'Reinmann A, Bruyneel AV, Gligorov J, Mesure S, Combescure C, Koessler T, Bodmer A. Influence of chemotherapy on postural control and quality of life in women with gynaecological cancer: a protocol of a prospective observational study. BMJ Open. 2022 Sep 7;12(9):e061664. doi: 10.1136/bmjopen-2022-061664.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to understand the strategies for adapting postural control in patients who have received chemotherapy treatment for gynaecological cancer.', 'detailedDescription': 'Chemotherapy can cause many side effects, including peripheral neuropathies. Chemotherapy induced peripheral neuropathies (CIPN) are primarily sensory impairments that can alter the signals for somatosensory feedback and thus affect the postural control in the standing position. The objective of this study is to evaluate the impact of chemotherapy and peripheral neuropathies on postural control in the standing position. As balance maintenance is a complex construct involving different systems, this study will evaluate maintenance strategies during sensory disturbances in order to better understand post-chemotherapy coping strategies. These sensory disturbances concern vision (eyes closed) and the alteration of the somatosensory system (foam under the feet and vibration system). In addition, this study will evaluate balance in double task situations and dynamic stability. Given the consequent impact of chemotherapy and peripheral neuropathies on quality of life, a quality of life questionnaire will also be administered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of 31 women between the ages of 18 and 65 consulting at the University Hospitals for their oncological disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen\n\n* between 18 and 65 years;\n* with a gynaecological cancer about to start chemotherapy known to be neurotoxic (paclitaxel, docetaxel, nab-paclitaxel, or paclitaxel-carboplatin);\n* able to stand upright for 30 s on a flat surface without assistance;\n* able to provide written consent\n\nExclusion Criteria:\n\nWomen\n\n* with pre-existing vestibular, uncorrectable visual, or somatosensory disorders or other pathologies altering postural control that would influence testing;\n* with exposure to known neurotoxic chemotherapy (paclitaxel, docetaxel, nab-paclitaxel, vinorelbine, trastuzumab-emtansine, eribulin, or paclitaxel-carboplatin) that may have caused previous CIPN;\n* with an inability to perform the test due to poor comprehension of instructions or psychological problems.'}, 'identificationModule': {'nctId': 'NCT04692168', 'briefTitle': 'Influence of Chemotherapy on Postural Control in Women With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'School of Health Sciences Geneva'}, 'officialTitle': 'Influence of Chemotherapy on Postural Control and Quality of Life in Women With Gynaecological Cancer: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '105909'}, 'secondaryIdInfos': [{'id': '2020-01639', 'type': 'REGISTRY', 'domain': 'BASEC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Entire group', 'description': 'The group will be test prior and three months after a neurotoxic chemotherapy for gynecological cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Aline Reinmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Health Sciences Geneva'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available within 6 months of study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcomes will be made available.', 'accessCriteria': 'At the end of the project the data will be deposited in the Yareta repository developed by the University of Geneva OR in an institutional repository. This choice will ensure that data is archived and shared in accordance with FAIR principles (Findability, Accessibility, Interoperability, and Reuse of digital assets).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aline Reinmann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aline Reinmann', 'investigatorAffiliation': 'School of Health Sciences Geneva'}}}}