Laser vs Hyaluronic Acid for GSM in Breast Cancer

Study Overview
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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).

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.

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

Conditions
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Urogenital Disease

Intervention / Treatment
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* Device: Cikatridina
* Device: Juliet Feminine Laser


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hyaluronic acid suppository therapy<br>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. | Device: Cikatridina<br>* Women are asked to insert the suppositories according to the manufacturer's protocol.<br>|
| Active Comparator: Juliet feminine laser<br>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. | Device: Juliet Feminine Laser<br>* Women will receive the laser treatment twice during the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms severity- visual analogue scale | A visual analogue scale (VAS) is used for assessment for the subjective bother of GSM. The lower the score the less bothering are the symptoms. | 3 months | 
| Treatment discomfort / pain; assessed by visual analogue scale | At the end of each laser treatment session or at 3 months for the vaginal suppository group patients are asked to indicate the degree of discomfort or pain during laser therapy/vaginal insertion of the suppositories on a scale ranging from 0 (no discomfort/pain) to 10 (worst possible discomfort/pain) | 3 months | 
| Patient Global Impression of Improvement | The Patient Global Impression of Improvement (PGI-I) are robust and valid instruments to assess disease severity, bother and improvement after treatment in women. It ranges from very much improved to a lot worse on 7 likert scale. | 3 months | 
| Patient Global Impression of Severity | The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe. | 3 months | 
| Female Sexual health | The Female Sexual health is assessed with the European Organisation for Research and Treatment of Cancer (EORTC) sexual health questionnaire and is a validated questionnaire which assesses physical, psychological, and social aspects of sexuality of cancer survivors. It is a 22 item questionnaire.The higher the score the better is the sexual function. | 3 months | 
| pelvic floor symptoms | A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have. | 3 months | 
| Patient satisfaction with treatment/ inpatient management | Fragebogen zur Patientenzufriedenheit - ZUF8. The questionnaire, the German version of the original Client Satisfaction Questionnaire-CSQ8, is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The Zuf-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score the higher is the patient satiscation. | 3 months | 
| Discontinuation rate | Number of patients who discontinue treatment | 3 months | 
| Dyspareunia rate | evaluated by a single item of the Baessler questionnaire. The rate will be given in number and percent. | 3 months | 
| Quality of life: EORTC quality of life questionnaire | Determined by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire. The questionnaire is a 47 item questionnaire and assess quality of life. The lower the score the better the quality of life. | 3 months |