Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy

This is an interventional treatment trial for Anatomic Stage 0 Breast Cancer AJCC v8 Read More

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 to enrollment
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

• Previous use of CO2 fractional within 1 year
• Receiving any form of hormone replacement therapy, including topical estrogens, testosterone, and dehydroepiandrosterone (DHEA) or selective estrogen receptor modulator (SERM), including tamoxifen and ospemifene
• History of or current dysplastic nevi in the area that will be treated
• Prolapse uterus > stage II according to the International Continence Society pelvic organ prolapse quantification (ICS-POP-Q) system
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the treatment
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Evidence of urinary tract infection (UTI) based on the urinalysis (UA) at the time of the screening. Patients with evidence of UTI can be enrolled after UTI is treated and repeated UA and/or urine culture shows no further evidence of ongoing infection
• Evidence of injuries, bleeding, or evidence suggestive of dysplasia in the external vaginal area or vaginal canal