The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)

NCT06318052 | Recruiting

• 1 other identifier: LUM-ABU-CO2-FemTouch-19-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment.

Conditions

Vaginal Atrophy Patients With GSM

Outcome Measures

Primary Outcomes (1)

• To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment

  Efficacy will be determined by an improvement from baseline to post-treatment in the score of the Vaginal Assessment Scale (VAS), mean of 4 items scored 0-3; 0=none 3=severe; higher score = worse condition.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment

  Through study completion, an average of 1 year

• To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment.

  Through study completion, an average of 1 year

Study Arms (2)

CO2 laser treatment

EXPERIMENTAL

The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology. The system enables the delivery of laser energy along the vaginal walls. Through the use of the scanner, this laser energy is delivered in a fractional manner, selectively treating less than 100% of the tissue surface. This allows the tissue to heal much faster than when treating non-fractionally (100% of the surface) because much of the tissue is left unharmed, while the efficacy of the treatment remains significant.

Device: The FemTouch delivery system

Gynomunal gel treatment

ACTIVE COMPARATOR

Gynomunal is a hormone/free, vaginal moisturizing gel for women with vaginal dryness. Gynomunal has been clinically proven in treating vaginal dryness, and its symptoms, including itching, burning, and pain (as well as discomfort during sex). Gynomunal is a liposomal formulation containing natural hop extract, Vitamin E and hyaluronic acid.

Drug: Gynomunal gel treatment

Interventions

The FemTouch delivery system DEVICE

The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology

CO2 laser treatment

Gynomunal gel treatment DRUG

hormone/free, vaginal moisturizing gel for women with vaginal dryness

Gynomunal gel treatment

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptor and her2 neu status who have completed cancer-related treatment\>=6 months prior to enrollment with no evidence of metastasis or currently active disease
• Women currently on endocrine therapy, single agent Herceptin, or observation
• Patient-reported dyspareunia and/or vaginal dryness with the severity of \>=4 on a scale from 0 (none) to 10 (most severe) that has been persistent for over \>= 4 weeks and/or the inability to be sexually active due to pain
• Age 21 to 70 years
• Subjects seeking treatment of GSM
• Objective evidence of menopause: percentage of superficial vaginal epithelial cells of vaginal smear (MI) ≤ 5% and Vaginal fluid pH \> 4.5 (for women within the first 3 years post-menopause)
• Normal Papanicolaou (PAP) test smear last performed as a standard of care
• Negative urine analysis
• Sexually active (having sexual intercourse at least once a month) or desire to maintain sexual activity
• Informed consent process completed and subject signed a consent form.
• Able and willing to comply with the treatment/follow-up schedule and requirements
• Patient is willing to use non-hormonal contraception method during the course of the study.

You may not qualify if:

• Active genital infection.
• Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpes or candida or (condyloma ) defined as \> 2 episodes in the recent year.
• Hormonal replacement therapies (local or systemic) within the last 6 weeks.
• Pelvic Organ Prolapse (POP ≥ 2) according to the pelvic organ prolapse quantification system (may be relative).
• Prior reconstructive pelvic mesh surgery.
• Previous surgery in the treated area in the last 6 months.
• Participation in a study of another device or drug within 6 months prior to enrollment or during this study, if treatments of the vagina were involved.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
• Patient is pregnant or planning to become pregnant within the next six months.

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Frauenarztpraxis Heussweg

Hamburg, 20255, Germany

RECRUITING

Study Officials

• Matthias Theden-Schow, Dr

  Central study center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Sachs

CONTACT

4210613; csachs98@googlemail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: March 19, 2024
• Study Start: November 1, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)