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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment | Efficacy of fractionated CO2 laser treatments will be determined by treatment completion rates (i.e. the number of women that complete the treatment regimen out of the randomized subjects). | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Sachs | Contact | 4210613 | 040 | csachs98@googlemail.com |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Theden-Schow, Dr | Central study center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frauenarztpraxis Heussweg | Recruiting | Hamburg | 20255 | Germany |
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| Gynomunal gel treatment | Drug | hormone/free, vaginal moisturizing gel for women with vaginal dryness |
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| To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment. | Efficacy of fractionated CO2 laser treatments will be determined by Subject Downtime evaluation. | Through study completion, an average of 1 year |