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Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, Revitalize Trial
Trial Status: active
This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be told whether they will be in the laser treatment group or the placebo group until 6-weeks after the third treatment visit (patient-blinded). At that point, patients who received placebo can elect to receive laser treatment similar to the other group. GSM is group of symptoms that affect the female genital and urinary systems and results from the lack of estrogen. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness compared to placebo.
Inclusion Criteria
Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation within 3 months prior to registration
Breast cancer survivors not currently on therapy are eligible
Patients may be receiving ongoing endocrine therapy. These patients must be receiving endocrine therapy prior to registration and intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient’s medical oncologist
* Patients who are receiving endocrine therapy +/- monoclonal therapy like trastuzumab and pertuzumab are eligible
Patients on targeted therapy such as CD4/6 inhibitors are not eligible. Patients receiving concurrent chemotherapy and immunotherapy are not eligible
Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as >= 4 on a 0-10-point scale that has been bothersome for >= 3 months and for which the patient wants to undergo the study procedure
No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible
No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis
No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (bilateral salpingo-oophorectomy) are eligible
No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and/or androgen therapy within 6 weeks prior to registration
No other suspected contraindications for undergoing laser therapy
No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible
No known concurrent invasive carcinoma/malignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment
Postmenopausal based on at least one of the following criteria at the time of registration:
* Women 50 or older with no spontaneous regular menses > 12 months
* On ovarian suppression (i.e., gonadotrophin releasing hormone [GNRH] agonist/antagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks
* Bilateral oophorectomy
* Women on aromatase inhibitor (AI) therapy (i.e., clinically judged to be postmenopausal)
In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish
Age >= 22 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of < 2 cm between the vaginal opening and the anal opening)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05379153.
Locations matching your search criteria
United States
Michigan
Ann Arbor
Trinity Health IHA - Obstetrics and Gynecology West Arbor
I. To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale.
SECONDARY OBJECTIVES:
I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female.
II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale.
III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy.
EXPLORATORY OBJECTIVES:
I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in reducing the severity of other patient-reported symptoms of the genitourinary syndrome of menopause (GSM) besides vaginal dryness based on an 11-point numerical analog scale.
II. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving other domains of sexual function besides vaginal discomfort during sexual activity based on the PROMIS Sexual Function v 2.0 Brief Profile- Female.
III. To evaluate satisfaction with vaginal fractional CO2 laser therapy.
IV. To describe long-term effects of vaginal fractional CO2 laser therapy.
V. To describe adjuvant endocrine therapy persistence with vaginal fractional CO2 laser treatment compared to placebo procedure in patients with hormone receptor positive (HR+) breast cancer who were taking adjuvant endocrine therapy at registration who are < 5 years out from initiation of endocrine therapy.
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OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Patients will also be asked to complete questionnaires before they start treatment, at every visit and one week after each of their visits.
After completion of study treatment, patients are followed up at 6 weeks, and 3, 6, 12, 18 and 24 months. At the 6 weeks follow-up visit, patients on Arm II may elect to cross-over to Arm I to receive laser treatment.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationAlliance for Clinical Trials in Oncology
