Laser vs Hyaluronic Acid for GSM in Breast Cancer
Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)
1 other identifier
interventional
50
1 country
1
Brief Summary
All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate. After 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. At 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2019
CompletedStudy Start
First participant enrolled
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 18, 2024
January 1, 2024
5.9 years
January 23, 2019
January 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
genitorurinary symptoms of menopause (GSM) determined by vaginal health index score
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.
3 months
Secondary Outcomes (10)
Symptoms severity- visual analogue scale
3 months
Treatment discomfort / pain; assessed by visual analogue scale
3 months
Patient Global Impression of Improvement
3 months
Patient Global Impression of Severity
3 months
Female Sexual health
3 months
- +5 more secondary outcomes
Study Arms (2)
hyaluronic acid suppository therapy
ACTIVE COMPARATORWomen 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.
Juliet feminine laser
ACTIVE COMPARATORThe 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.
Interventions
Women are asked to insert the suppositories according to the manufacturer's protocol.
Women will receive the laser treatment twice during the study period.
Eligibility Criteria
You may qualify if:
- genital symptoms of dryness/ burning/ irritation
- and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain
- and/or symptoms of urgency and dysuria or recurrent urinary tract infection
- Age 18-80
- History of BC and/ or DCIS
- Completed locoregional therapy
- Current antihormonal therapy for BC possible
- Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial
You may not qualify if:
- Current or past genitourinary malignancy
- Abnormal PAP smear
- Current genitourinary tract infection
- Abnormal uterine bleeding
- photosensitive medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics, Medical University Graz
Graz, 8045, Austria
Related Publications (2)
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: 36279690DERIVEDEuropean 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.
PMID: 35443258DERIVED
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 25, 2019
Study Start
January 24, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share