Fractional CO2 Laser Therapy for Survivors of Breast Malignancies (NCT03307044) | Clinical Trial Compass
CompletedNot Applicable
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
United States66 participantsStarted 2017-11-16
Plain-language summary
This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
* Symptoms of urogenital atrophy including dyspareunia or vaginal dryness
Exclusion Criteria:
* Patients with metastatic breast cancer
* Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
* Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
* Pelvic organ prolapse greater than stage II
* Prior reconstructive pelvic surgery involving mesh
* Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Vaginal Assessment Scale score
Timeframe: Baseline up to 4 weeks
2
Patient compliance rates
Timeframe: Up to 4 weeks
3
Feasibility of laser treatments defined by completion rates and tolerability of treatment
Timeframe: Up to 4 weeks
Trial details
NCT IDNCT03307044
SponsorOhio State University Comprehensive Cancer Center