Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Austria
Department of Obstetrics, Medical University Graz
RECRUITING
Graz
Contact Information
Primary
Daniela Gold, MD PhD
daniela.gold@medunigraz.at
004331638512201
Time Frame
Start Date: 2019-01-24
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 50
Treatments
Active_comparator: hyaluronic acid suppository therapy
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.
Active_comparator: Juliet feminine laser
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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov

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