Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 9:00 PM
Study NCT ID:
NCT03816735
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser vs Hyaluronic Acid for GSM in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genitorurinary symptoms of menopause (GSM) determined by vaginal health index score', 'timeFrame': '3 months', 'description': 'Vaginal Health Score Index (VHIS) evaluates the appearance of the vaginal mucosa (elasticity, pH, vaginal discharge, mucosal integrity and moisture) on a scale from 1 to 5 each. The lower the score the worse the symptom.'}], 'secondaryOutcomes': [{'measure': 'Symptoms severity- visual analogue scale', 'timeFrame': '3 months', 'description': 'A visual analogue scale (VAS) is used for assessment for the subjective bother of GSM. The lower the score the less bothering are the symptoms.'}, {'measure': 'Treatment discomfort / pain; assessed by visual analogue scale', 'timeFrame': '3 months', 'description': 'At the end of each laser treatment session or at 3 months for the vaginal suppository group patients are asked to indicate the degree of discomfort or pain during laser therapy/vaginal insertion of the suppositories on a scale ranging from 0 (no discomfort/pain) to 10 (worst possible discomfort/pain)'}, {'measure': 'Patient Global Impression of Improvement', 'timeFrame': '3 months', 'description': 'The Patient Global Impression of Improvement (PGI-I) are robust and valid instruments to assess disease severity, bother and improvement after treatment in women. It ranges from very much improved to a lot worse on 7 likert scale.'}, {'measure': 'Patient Global Impression of Severity', 'timeFrame': '3 months', 'description': 'The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.'}, {'measure': 'Female Sexual health', 'timeFrame': '3 months', 'description': 'The Female Sexual health is assessed with the European Organisation for Research and Treatment of Cancer (EORTC) sexual health questionnaire and is a validated questionnaire which assesses physical, psychological, and social aspects of sexuality of cancer survivors. It is a 22 item questionnaire.The higher the score the better is the sexual function.'}, {'measure': 'pelvic floor symptoms', 'timeFrame': '3 months', 'description': 'A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.'}, {'measure': 'Patient satisfaction with treatment/ inpatient management', 'timeFrame': '3 months', 'description': '"Fragebogen zur Patientenzufriedenheit - ZUF8". The questionnaire, the German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The Zuf-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score the higher is the patient satiscation.'}, {'measure': 'Discontinuation rate', 'timeFrame': '3 months', 'description': 'Number of patients who discontinue treatment'}, {'measure': 'Dyspareunia rate', 'timeFrame': '3 months', 'description': 'evaluated by a single item of the Baessler questionnaire. The rate will be given in number and percent.'}, {'measure': 'Quality of life: EORTC quality of life questionnaire', 'timeFrame': '3 months', 'description': 'Determined by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire. The questionnaire is a 47 item questionnaire and assess quality of life. The lower the score the better the quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urogenital Disease']}, 'referencesModule': {'references': [{'pmid': '36279690', 'type': 'DERIVED', 'citation': 'Gold D, Nicolay L, Avian A, Greimel E, Balic M, Pristauz-Telsnigg G, Tamussino K, Trutnovsky G. Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial. Maturitas. 2023 Jan;167:1-7. doi: 10.1016/j.maturitas.2022.08.013. Epub 2022 Sep 9.'}, {'pmid': '35443258', 'type': 'DERIVED', 'citation': 'European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate.\n\nAfter informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. Laser treatment will be performed twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up.\n\nAt baseline and three months follow-up the following questionnaires will be filled out (VAS, (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC quality of life questionnaire, ZUF-8).', 'detailedDescription': 'Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress Urinary Incontinence), GSM and vaginal laxity. Asclepion\' s headquarters are located in "Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany".\n\nDevice II- Suppository The second device is a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH\'s headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* genital symptoms of dryness/ burning/ irritation\n\n * and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain\n * and/or symptoms of urgency and dysuria or recurrent urinary tract infection\n* Age 18-80\n* History of BC and/ or DCIS\n* Completed locoregional therapy\n* Current antihormonal therapy for BC possible\n* Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial\n\nExclusion criteria:\n\n* Current or past genitourinary malignancy\n* Abnormal PAP smear\n* Current genitourinary tract infection\n* Abnormal uterine bleeding\n* photosensitive medication'}, 'identificationModule': {'nctId': 'NCT03816735', 'briefTitle': 'Laser vs Hyaluronic Acid for GSM in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)', 'orgStudyIdInfo': {'id': '30-225 ex 17/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hyaluronic acid suppository therapy', 'description': 'Women receive a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH\'s headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria. The suppositories contain ontain hyaluronic acid, tea tree oil, tigergras extract, and aloe vera.', 'interventionNames': ['Device: Cikatridina']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Juliet feminine laser', 'description': 'The fractional microablative laser with 2940 nm wavelength has a high degree of absorption in water and selectively stimulates the synthesis of sub-mucosal collagen. The erbium-doped yttrium-aluminum-garnet (Er:YAG) laser has been successfully used in the field of plastic skin rejuvenation and reconstruction. The procedure is based on photothermic treatment of connective tissue: It has been established in animal and human studies that it affects collagen remodeling resulting in tightening of the supportive tissue.', 'interventionNames': ['Device: Juliet Feminine Laser']}], 'interventions': [{'name': 'Cikatridina', 'type': 'DEVICE', 'description': "Women are asked to insert the suppositories according to the manufacturer's protocol.", 'armGroupLabels': ['hyaluronic acid suppository therapy']}, {'name': 'Juliet Feminine Laser', 'type': 'DEVICE', 'description': 'Women will receive the laser treatment twice during the study period.', 'armGroupLabels': ['Juliet feminine laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8045', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniela Gold (Ulrich), MD, PhD', 'role': 'CONTACT', 'email': 'daniela.gold@medunigraz.at', 'phone': '+4331638512201'}, {'name': 'Daniela Gold, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karl Tamussino, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gerda Trutnovsky, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Obstetrics, Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Daniela Gold, MD PhD', 'role': 'CONTACT', 'email': 'daniela.gold@medunigraz.at', 'phone': '004331638512201'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}