Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT07201194
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holistic Acupuncture for Patients With Chemotherapy Induced Nausea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The project employs a crossover design, in which the patients participate in both the intervention and the control group. Participants are randomized into two groups: one group receives the intervention first and subsequently serves as the control group, while the other group starts as the control and later receives the intervention.\n\nBased on a holistic and individualized consultation, participants in the intervention group will receive one treatment with holistic acupuncture and acupressure in connection with a standard chemotherapy session, including standard supportive care for nausea. The control group will receive standard chemotherapy and supportive care only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient reported use of antiemetic medicine', 'timeFrame': '8 and 22 days after enrollment'}], 'primaryOutcomes': [{'measure': 'Patient reported nausea assessed on the EORTC-15-PAL Scale', 'timeFrame': '8 days after enrollment'}], 'secondaryOutcomes': [{'measure': 'Patient reported symptom intensity according to the EORTC-15 PAL Scale', 'timeFrame': '8 and 22 days after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'chemotherapy induced nauseau'], 'conditions': ['Breast Cancer', 'Prostate Cancer', 'Lung Cancer', 'Gynaecologic Cancer', 'Colorectal Cancer', 'Pancreatic Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'The study explores whether acupuncture as a supplement to conventional antiemetic medicine is superior in reducing the level of chemotherapy induced nausea compared to conventional anitemetic medicine alone.\n\nA total of 90 patients experiencing chemotherapy induced nausea will be allocated 1:1 to either acupuncture and antiemetic medicine or antiemetic medicine alone.\n\nThe level of nausea and other cancer related symptoms will be assessed at baseline and 8 and 22 days after enrollment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* ≥ 18 years of age\n* Undergoing chemotherapy and experiencing nausea despite adherence to the prescribed antiemetic regimen\n* Understands and speaks Danish\n* Written and orally informed consent\n* Planned for treatment every 14 days\n* At least two chemotherapy cycles planned at the time of inclusion\n\nExclusion Criteria:\n\n* Brain metastases\n* Performance status \\>2'}, 'identificationModule': {'nctId': 'NCT07201194', 'briefTitle': 'Holistic Acupuncture for Patients With Chemotherapy Induced Nausea', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea', 'orgStudyIdInfo': {'id': 'HOL-AKU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Holistic acupuncture and acupressure', 'description': 'Holistic acupuncture and acupressure as a supplement to standard care', 'interventionNames': ['Other: Holistic acupuncture and acupressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'interventionNames': ['Other: Standard medical treatment']}], 'interventions': [{'name': 'Holistic acupuncture and acupressure', 'type': 'OTHER', 'description': 'The intervention consists of one holistic and individualized consultation with an oncologist trained in acupuncture, in connection with outpatient chemotherapy. The consultation follows the principles of Traditional Chinese Medicine (TCM). The theoretical framework applied is Zang-Fu, which describes organ imbalances and aligns closely with Western medical understanding.\n\nBased on individual assessment and anamnesis, the patient receives acupuncture combined with acupressure.\n\nA maximum of 10 needles will be used, regardless of whether a deficiency or excess condition is identified. The acupuncture needles used are CAIR Super Silicon CSC-1, size 0.20 × 25 mm. The needles are inserted perpendicularly, except for Yin Tang, which is inserted transversely. The needles will remain in place for 25 minutes.', 'armGroupLabels': ['Holistic acupuncture and acupressure']}, {'name': 'Standard medical treatment', 'type': 'OTHER', 'description': "Standard treatment and care includes chemotherapy, supportive antiemetic medication, close monitoring, and management of the patient's symptoms, side effects, and overall health.", 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Department of Oncology, Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Mette Stie, PhD', 'role': 'CONTACT', 'email': 'mette.stie@rsyd.dk', 'phone': '+4579409174'}, {'name': 'Nanna Nordestgaard Madsen, MScN', 'role': 'CONTACT', 'email': 'nanna.nordestgaard.madsen@rsyd.dk', 'phone': '+4579406095'}], 'overallOfficials': [{'name': 'Mette Stie, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Lillebaelt Hospital, Vejle'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}