Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 11:40 AM
Study NCT ID:
NCT03628092
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D053159', 'term': 'Dysuria'}], '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': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal dryness', 'timeFrame': '12 weeks after completion of treatment', 'description': 'Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible.'}], 'secondaryOutcomes': [{'measure': 'Other symptoms of vulvovaginal atrophy', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)'}, {'measure': 'Maturation index', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture)\n\n)'}, {'measure': 'Vaginal pH', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Improvement in vaginal pH'}, {'measure': 'Clinician Assessed Changes', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours).'}, {'measure': 'Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': "Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life."}, {'measure': 'Sexual Function', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool'}, {'measure': 'Satisfaction with treatment assessed on a Likert Scale', 'timeFrame': '12 weeks after completion of treatment and 12 months after active treatment', 'description': 'Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree)'}, {'measure': 'Safety of laser treatment (Side effects)', 'timeFrame': '15 months', 'description': 'Side effects reported over the duration of the study will be collected descriptively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genitourinary symptoms of menopause', 'CO2 fractional ablative laser', 'Early breast cancer', 'Vulvovaginal atrophy', 'Vaginal dryness', 'Dyspareunia', 'Vaginal itch', 'Dysuria'], 'conditions': ['Vulvovaginal Atrophy', 'Genitourinary Symptoms and Ill-Defined Conditions']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.', 'detailedDescription': 'LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)\n\nParticipants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with a history of early breast cancer \\>18 years of age\n* At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.\n* Three groups of patients will qualify:\n* Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \\>6 months\n* Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor\n* Postmenopausal women on tamoxifen or an aromatase inhibitor\n* Willingness to give written informed consent and willingness to comply with the study\n* Up to date pap test / HPV (human papillomavirus) testing\n\nExclusion Criteria:\n\n* Medical contraindication to the use of fractional ablative CO2 laser\n* Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment\n* Use of vaginal lubricants or moisturisers 14 days prior to the study treatment\n* Active or recent genitourinary infections (\\<30 days)\n* Genital prolapse (grade III)\n* Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts)\n* Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)"}, 'identificationModule': {'nctId': 'NCT03628092', 'acronym': 'LAAVA2', 'briefTitle': 'Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Royal North Shore Hospital'}, 'officialTitle': 'Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'LAAVA2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CO2 Fractional Ablative Laser', 'description': '3 treatments approximately 4 weeks apart with vaginal/vulval laser', 'interventionNames': ['Device: CO2 Fractional Ablative Laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '3 treatments approximately 4 weeks apart with "sham" laser', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'CO2 Fractional Ablative Laser', 'type': 'DEVICE', 'otherNames': ['Monalisa Touch', 'Lotus'], 'description': 'Vaginal / vulval laser treatment', 'armGroupLabels': ['CO2 Fractional Ablative Laser']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'Sham Device', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2065', 'city': 'Saint Leonards', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Antonia Pearson, BMed FRACP', 'role': 'CONTACT', 'email': 'antonia.pearson@sydney.edu.au', 'phone': '+61402308664'}, {'name': 'Emily Forward, MBBS MBA BSc', 'role': 'CONTACT', 'email': 'eforward.derm@gmail.com', 'phone': '+61 2 9462 9657'}, {'name': 'Antonia Pearson, BMed FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emily Forward, MBBS MBA Bsc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gail Fischer, OAM FACD MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sally Baron-Hay, MBBS FRACP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royal North Shore Hospital'}, {'zip': '2074', 'city': 'Wahroonga', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rebecca Stevenson', 'role': 'CONTACT', 'email': 'Rebecca.Stevenson@sah.org.au', 'phone': '+612 9480 6283'}, {'name': 'Nina Singh', 'role': 'CONTACT', 'email': 'Nina.Singh@sah.org.au', 'phone': '+612 9480 6280'}, {'name': 'Gavin Marx, MBBS FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrew Booker, BMedFRANZCOG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}], 'centralContacts': [{'name': 'Antonia Pearson, BMed', 'role': 'CONTACT', 'email': 'antonia.pearson@sydney.edu.au', 'phone': '+61402308664'}, {'name': 'Emily Forward, MBBS MBA BSc', 'role': 'CONTACT', 'email': 'eforward.derm@gmail.com', 'phone': '+61 2 9462 9657'}], 'overallOfficials': [{'name': 'Antonia Pearson, BMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal North Shore Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal North Shore Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}