Laser vs Hyaluronic Acid for GSM in Breast Cancer

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

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).

Study Overview

• Status: Recruiting
• Conditions: Urogenital Disease
• Intervention / Treatment: Device: Cikatridina; Device: Juliet Feminine Laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Gold, MD PhD; Phone Number: 004331638512201; Email: daniela.gold@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8045
    • Recruiting
    • Department of Obstetrics, Medical University Graz
    • Sub-Investigator: Karl Tamussino, MD
    • Sub-Investigator: Gerda Trutnovsky, MD
    • Contact: Daniela Gold (Ulrich), MD, PhD; Phone Number: +4331638512201; Email: daniela.gold@medunigraz.at
    • Principal Investigator: Daniela Gold, M.D. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Cikatridina; Women are asked to insert the suppositories according to the manufacturer's protocol.
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.	Device: Juliet Feminine Laser; Women will receive the laser treatment twice during the study period.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

General Publications

• Gold D, Nicolay L, Avian A, Greimel E, Balic M, Pristauz-Telsnigg G, Tamussino K, Trutnovsky G. Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial. Maturitas. 2023 Jan;167:1-7. doi: 10.1016/j.maturitas.2022.08.013. Epub 2022 Sep 9.
• European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases
• Other Study ID Numbers: 30-225 ex 17/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No