Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:17 AM
Study NCT ID:
NCT07464769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 358}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN), defined as the absolute increase from the patient's baseline score in the EORTC CIPN20 sensory PN subscale.", 'timeFrame': "This is determined by using the patient's highest reported score from treatment start and up to 6-10 weeks after the final dose (1-24 weeks of treatment)."}], 'secondaryOutcomes': [{'measure': 'Difference in relative dose intensity of taxane respectively oxaliplatin.', 'timeFrame': 'From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Colorectal Cancer', 'Taxan', 'Oxaliplatin', 'Compression therapy', 'Prevention'], 'conditions': ['Peripheral Neuropathy Due to Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Population Cohort 1 Taxane: Breast cancer patients; (neo-)adjuvant treatment Cohort 2 Oxaliplatin: Colorectal cancer patients; (neo-)adjuvant treatment Study design Multicentre, unblinded randomised controlled study Study rationale Chemotherapy-induced peripheral neuropathy is a dose-limiting side effect during treatment and cause persistent impairment and worsening of quality of life in cancer survivors.\n\nCompression therapy could be a plausible preventive intervention, although practice changing studies are lacking.\n\nAims To investigate if compression therapy of the hands and feet can reduce the prevalence of both acute and persistent CIPN symptoms caused by taxanes or oxaliplatin. Furthermore, to investigate if compression therapy impact the level of taxane or oxaliplatin dose reductions.\n\nEndpoints Primary endpoint\n\n* The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN) Selected secondary endpoints\n* Key secondary endpoint: Difference in relative dose intensity of taxane respectively oxaliplatin.\n* The difference in the occurrence of motor and autonomic chemotherapy-induced peripheral neuropathy (CIPN).\n* Difference in occurrence of persistent patient-reported CIPN symptoms 1, 3 and 5 years after start of neurotoxic chemotherapy (EORTC CIPN20)\n* Health-related quality of life at baseline and after 1, 3, 5 years (EORTC QLQ C30) Exploratory endpoints\n* Prevalence of autonomic neurotoxicity after neurotoxic treatment, defined as increase of prevalence from baseline to one year after treatment.\n\nSubstudy\n\n• Development of pharmacogenetic risk prediction models of acute respectively persistent taxane induced peripheral neuropathy.\n\nSample size Randomisation 1:1, per site Taxane cohort 268 breast cancer patients, stratification on taxane type Oxaliplatin cohort 90 colorectal cancer patients, stratification on length of treatment Follow-up Patient-reported CIPN symptoms during treatment and at time point up to 5 years post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\no Scheduled neurotoxic treatment in any of the following settings: Taxane cohort\n\n* Breast cancer patients planned for either neoadjuvant or adjuvant taxane treatment Oxaliplatin cohort\n* Rectal cancer patients planned for total neoadjuvant treatment including oxaliplatin\n* Colorectal cancer patients planned for adjuvant chemotherapy including oxaliplatin, without prior neoadjuvant oxaliplatin treatment\n* Understand written and oral Swedish.\n\nExclusion Criteria:\n\n* Previous neurotoxic chemotherapy\\* treatment\n* Distant metastases\n* Any psychiatric disorder or health disorder that causes an inability to make an informed consent to participate.\n* Any manifest clinically significant peripheral neuropathy according to treating physician.\n* Current lymphoedema in limbs requiring compression therapy.\n* Ongoing pregnancy.\n* Planned taxane or oxaliplatin treatment shorter than 8 weeks or longer than 26 weeks\n* Planned compression or cryotherapy of hands and/or feet during taxane or oxaliplatin\n\n * Taxanes (docetaxel, paclitaxel, nabpaclitaxel), platinum components (carboplatin, oxaplatin, cisplatin), vinca-alkaloids (vincristine, vinblastine, vinorelbine, eribulin), bortezomid, thalidomide, antibody drug conjugate including vedotin or emtansine.'}, 'identificationModule': {'nctId': 'NCT07464769', 'acronym': 'KompXX', 'briefTitle': 'Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Jönköping County'}, 'officialTitle': 'A Randomized Controlled Study of Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '2025-08840-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Taxane or Oxaliplatin', 'description': 'Use of compression therapy class 2 (approximately 20-32 mmHg) garments on feet/lower leg and hand/lower arm', 'interventionNames': ['Other: Compression therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Taxane or oxaliplatin', 'description': 'No intervention as standard therapy'}], 'interventions': [{'name': 'Compression therapy', 'type': 'OTHER', 'description': 'Compression garments class 2', 'armGroupLabels': ['Taxane or Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}], 'centralContacts': [{'name': 'Kristina Engvall, MD PhD', 'role': 'CONTACT', 'email': 'kompxx.onkologkliniken@rjl.se', 'phone': '010242100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Jönköping County', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}