Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether vaginal CO2 laser treatment helps vaginal dryness more than a fake treatment with no active therapy. It is for breast cancer survivors who are past menopause and have bothersome vaginal dryness.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 22 or older who have had breast cancer.
- Vaginal dryness rated at least 4 out of 10, with or without pain during sex. It must have been bothersome for at least 3 months, and you must want the study treatment.
- Past menopause: age 50 or older with no regular periods for over 12 months; both ovaries removed; taking an aromatase inhibitor; or taking medicine to stop the ovaries from working for at least 6 months, with plans to continue for at least 18 weeks.
- Breast cancer survivors who are not on cancer treatment may join.
- Ongoing hormone-blocking cancer treatment is allowed. You must plan to stay on the same treatment for 4 months unless your cancer doctor says a change is needed. Trastuzumab or pertuzumab with this treatment is allowed.
- Able to speak, read, and understand English or Spanish to complete study forms.
- Able to do all usual activities, or limited only in hard physical activity.
Who can't join
- Chemotherapy, targeted therapy, immune therapy, or radiation within the past 3 months. Current targeted drugs such as CD4/6 inhibitors, chemotherapy, or immune therapy are not allowed, except for the treatments listed as allowed above.
- Past cancer of the female reproductive organs, abnormal cells in the vagina, radiation to the pelvis, or pelvic repair surgery using mesh. Abnormal cells in the cervix are allowed.
- A history of certain immune, skin, muscle, or connective tissue diseases, including lupus, scleroderma, systemic sclerosis, mixed or undifferentiated connective tissue disease, collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis, or vulvar vestibulitis.
- Pelvic surgery with a cut in the vagina within 6 months. Surgery through small belly cuts to remove both ovaries and fallopian tubes is allowed.
- Estrogen or progesterone that acts throughout the body, vaginal estrogen, vaginal prasterone, ospemifene, or androgen treatment within 6 weeks.
- Any past vaginal laser treatment, or another suspected reason laser treatment would be unsafe.
- Another current invasive cancer. Cancer that has not spread beyond its starting layer may be allowed. Past cancer may be allowed if you are off treatment and it would not affect the study.
- A history of thick, raised scars called keloids; an abnormal opening involving the genitals called a fistula; or less than 2 centimeters between the vaginal and anal openings.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 adjuvant 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 sites (2)
MI
- Trinity Health IHA - Obstetrics and Gynecology West Arbor · Ann Arbor, MI 48103Site Public Contact · Study contact · MCRCwebsitecontactform@stjoeshealth.orgGina B. Long · Principal investigatorMore trials in Ann Arbor
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210More trials in Columbus