Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positi… (NCT03666819) | Clinical Trial Compass
WithdrawnPhase 2
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
Stopped: Manufacturer will not be supporting this study
0Started 2018-09-10
Plain-language summary
This phase II trial studies how well carbon dioxide fractional (CO2RE) laser works in treating participants with stage 0-III hormone receptor-positive breast cancer with vulvovaginal atrophy associated with dryness, inflammation or thinning of the epithelial lining of the vulva and vagina. CO2RE laser is a device that delivers controlled CO2 energy to the vaginal tissue and may help treat vaginal symptoms such as itching, burning, painful sexual intercourse, thickened or thin skin of the vulva, and stinging.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Histological confirmation of adenocarcinoma of the breast stage 0-III
* Evidence of hormone sensitivity with estrogen receptor (ER) and/or progesterone receptor (PR) positive \>= 1% of primary tumor tissue
* Currently or will be starting on aromatase inhibitor (letrozole, anastrozole, or exemestane)
* Willingness to self-report vaginal itching, dryness, or dyspareunia
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Obtained =\< 28 days prior to registration: Hemoglobin \>= 8.0 g/dL
* Obtained =\< 28 days prior to registration: Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Obtained =\< 28 days prior to registration: Platelet count \>= 75,000/mm\^3
* Obtained =\< 28 days prior to registration: Total bilirubin =\< 3.0 x upper limit of normal (ULN)
* Obtained =\< 28 days prior to registration: Aspartate transaminase (AST) =\< 3 x ULN
* Obtained =\< 28 days prior to registration: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 2 x ULN OR if patient is receiving anticoagulant therapy and PT/INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of coagulants
* Obtained =\< 28 days prior to registration: Calculated creatinine clearance =\< 3 x ULN
* Recent negative Papanicolaou (PAP) smear within 1 year. In patients who do not have recent PAP smear, PAP smear should be obtained as per standard of care during the screening process prior t…
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
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)