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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
The FemTouch delivery system is used in conjunction with the AcuPulse CO2 laser system and the AcuScan120 microscanner to provide fractional treatments in gynecology
hormone/free, vaginal moisturizing gel for women with vaginal dryness
Frauenarztpraxis Heussweg
Hamburg, Germany
RECRUITINGTo 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.
Time frame: 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
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).
Time frame: 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.
Efficacy of fractionated CO2 laser treatments will be determined by Subject Downtime evaluation.
Time frame: Through study completion, an average of 1 year
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