Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-10 @ 3:17 AM
Study NCT ID:
NCT00408759
Status:
UNKNOWN
Last Update Posted:
2006-12-07
First Post:
2006-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2006-12-06', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-06', 'lastUpdatePostDateStruct': {'date': '2006-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'salivaa volume'}, {'measure': 'quality of life related to salivation'}]}, 'conditionsModule': {'keywords': ['xerostomia', 'hypnosis', 'dry mouth', 'radiotherapy', 'head and neck cancer'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': 'xerostomia develops in all patients with head and neck cancer following radiotherapy. it consists one of the main side effects which affects quality of life. currently, there is no standard of care for treating this condition. parasympathomimetic drugs may help but carry significant side effects.\n\nhypnosis may affect autonomic function such as salivation, in healthy people.in this study we will explore the efficacy of hypnosis in improving salivation, in the patient population.', 'detailedDescription': '10 head and neck cancer patients with xerostomia following radiotherapy will be assessed for severity of xerostomia using questionnares and quantitative salivation tests. patients responsive to citric acid will receive a hypnotic session with specific suggestion for salivation. saliva volume will be assessed pre and post hypnosis. patients will receive a CD with recorded hypnotic session to use freely at home. xerostomia will be assessed using a questionnare one week following hypnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radiotherapy for head and neck cancer\n* xerostomia\n\nExclusion Criteria:\n\n* psychiatric illness (present or past)'}, 'identificationModule': {'nctId': 'NCT00408759', 'briefTitle': 'Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients', 'orgStudyIdInfo': {'id': 'eschiff'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hypnosis', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'elad schiff', 'role': 'CONTACT', 'email': 'eschiff@email.arizona.edu', 'phone': '97248359767'}, {'name': 'Gorge Mogilner', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noam Yarom', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilana Dowek', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'bnai zion MC', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'elad schiff', 'role': 'CONTACT', 'email': 'eschiff@email.arizona.edu', 'phone': '972482654767'}, {'name': 'gorge mogilner', 'role': 'CONTACT', 'email': 'eschiff@bezeqint.net', 'phone': '97248359359'}], 'overallOfficials': [{'name': 'Elad Schiff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bnai Zion MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}}}}