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Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
Phase II Trial of CO2RE Laser for Patients With Stage 0-III Hormone Receptor-Positive Breast Cancer on Aromatase Inhibitors With Vulvovaginal Atrophy
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2018
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2021
CompletedJanuary 6, 2023
October 1, 2018
3 years
September 10, 2018
January 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
Descriptive statistics (mean, standard deviation \[SD\], median, interquartile range \[IQR\]) using frequency table and histogram will be used to summarize the reduction in the sum of VSQ total score first three scales of the VSQ (symptoms, emotions, and life-impact) at 3 months after treatment versus (vs.) baseline.
Baseline up to 3 months
Secondary Outcomes (9)
Reduction in VSQ score (symptoms, emotions, and life-impact)
Baseline up to 12 months
Female Sexual Function Index (FSFI) score
Baseline up to 12 months
Urogenital Distress Inventory (UDI) 6 score
Baseline up to 12 months
Vaginal health index score
Baseline up to 12 months
Vaginal caliber
Baseline up to 12 months
- +4 more secondary outcomes
Other Outcomes (2)
Change in vaginal cytology using vaginal maturation index
Baseline up to 12 months
Assessment of serum estradiol levels
Baseline up to 12 months
Study Arms (1)
Treatment (carbon dioxide fractional laser)
EXPERIMENTALParticipants undergo carbon dioxide fractional laser therapy over 10-15 minutes on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo CO2RE laser therapy
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saranya Chumsri
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
September 10, 2018
Primary Completion
September 10, 2021
Study Completion
September 10, 2021
Last Updated
January 6, 2023
Record last verified: 2018-10