Laser vs Hyaluronic Acid for GSM in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-24

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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".

Device 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.

Conditions

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Urogenital Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized open study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cikatridina

Intervention Type DEVICE

Women are asked to insert the suppositories according to the manufacturer's protocol.

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.

Group Type ACTIVE_COMPARATOR

Juliet Feminine Laser

Intervention Type DEVICE

Women will receive the laser treatment twice during the study period.

Interventions

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Cikatridina

Women are asked to insert the suppositories according to the manufacturer's protocol.

Intervention Type DEVICE

Juliet Feminine Laser

Women will receive the laser treatment twice during the study period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Current or past genitourinary malignancy
* Abnormal PAP smear
* Current genitourinary tract infection
* Abnormal uterine bleeding
* photosensitive medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes