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New treatment option for Anatomic Stage 0 Breast Cancer AJCC v8
Official title Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
ClinicalTrials.gov ID: NCT05379153
What this study is testing
- What it's testing
- This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without...
- May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +/- ovarian function suppression). Patients are not required to receive...
- 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...
- No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility
- No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with...
See the full eligibility criteria
- Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and/or radiation) \>= 12 months...
- May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +/- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant...
- 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...
- No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility
- 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...
- No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingooophorectomy) 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...
- 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 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.