Laser vs Hyaluronic Acid for GSM in Breast Cancer

Urogenital Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816735
• Other study ID #: 30-225 ex 17/18
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: Daniela Gold, MD PhD
• Phone: 004331638512201
• Email: daniela.gold[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urogenital Disease
• Urogenital Diseases

Intervention

Device:
• Cikatridina
Women are asked to insert the suppositories according to the manufacturer's protocol.
• Juliet Feminine Laser
Women will receive the laser treatment twice during the study period.

Locations

Country	Name	City	State
Austria	Department of Obstetrics, Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Discontinuation rate	Number of patients who discontinue treatment	3 months
Secondary	Dyspareunia rate	evaluated by a single item of the Baessler questionnaire. The rate will be given in number and percent.	3 months
Secondary	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