Clinical trial NCT06318052: The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
Official title: The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Atrophy Patients With GSM
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 68
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: GSM-related symptoms significantly decrease the quality of life of post-menopausal women and harm the quality of life of up to seventy-five percent of breast cancer survivors who suffer from one or more GSM symptoms. Although varieties of hormonal and non-hormonal treatment options are available for post-menopausal women, the level of compliance is variable. One of the main reasons is the discomfort associated with the use of these measures, and in case of hormonal therapies certain risks and side effects. For cancer survivors, the possibility of having hormonal treatment must be considered against the possibility of increasing the risk of reoccurrence.

Therefore, women afflicted with GSM, whether it is age-related GSM or post-cancer GSM, are in need of additional therapeutic alternatives. Recently, supportive evidence is being gathered, showing that laser treatments to vaginal mucosa for GSM related symptoms are safe and effective. A prospective randomized comparative study comparing non-hormonal gel treatment to fractional CO2 vaginal laser treatment will contribute to optimizing treatment in this patient population

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment
timeFrame: Through study completion, an average of 1 year
measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Frauenarztpraxis Heussweg
Study officials:
affiliation: Central study center
name: Matthias Theden-Schow, Dr
role: PRINCIPAL_INVESTIGATOR
References: