Laser vs Hyaluronic Acid for GSM in Breast Cancer

Medical University of Graz

Status: Enrolling

Conditions: Urogenital Disease

Treatments: Device: Juliet Feminine Laser; Device: Cikatridina

Study type: Interventional

Funder types: Other

Identifiers

NCT03816735

30-225 ex 17/18

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

hyaluronic acid suppository therapy

Active Comparator group

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.

Treatment:

Device: Cikatridina

Juliet feminine laser

Active Comparator group

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.

Treatment:

Device: Juliet Feminine Laser