Clinical trial NCT03666819: Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
Official title: Phase II Trial of CO2RE Laser for Patients With Stage 0-III Hormone Receptor-Positive Breast Cancer on Aromatase Inhibitors With Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Breast Adenocarcinoma
Dyspareunia
Estrogen Receptor Positive
Progesterone Receptor Positive
Prognostic Stage 0 Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Vaginal Dryness
Vaginal Itching
Vulvovaginal Atrophy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the reduction in Vulvovaginal Symptom Questionnaire (VSQ) score at 3-month follow up after CO2RE laser treatment.

SECONDARY OBJECTIVES:

I. To evaluate the reduction in VSQ score after CO2RE laser treatment 6-month follow-up and 12-month follow-up.

II. To evaluate Female Sexual Function Index (FSFI) score before and after treatment with CO2RE laser.

III. To evaluate Urogenital Distress Inventory (UDI) 6 score before and after treatment with CO2RE laser.

IV. To evaluate vaginal health index score and vaginal caliber before and after treatment with CO2RE laser.

V. To evaluate discomfort and pain during CO2RE laser treatment using the visual analog scale.

VI. To evaluate treatment satisfaction after CO2RE laser treatment using 5-point Likert scale.

VII. To evaluate adherence to aromatase inhibitor at 6 and 12 months after CO2RE laser treatment.

EXPLORATORY OBJECTIVES:

I. To assess the change in the vaginal cytology using vaginal maturation index at baseline and during follow-up.

II. To assess serum estradiol level at baseline and after CO2RE laser treatment.

OUTLINE:

Participants 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.

After completion of study treatment, participants are followed up at 3, 6, and 12 months.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
timeFrame: Baseline up to 3 months
Secondary outcomes:
measure: Reduction in VSQ score (symptoms, emotions, and life-impact)
timeFrame: Baseline up to 12 months
measure: Female Sexual Function Index (FSFI) score
timeFrame: Baseline up to 12 months
measure: Urogenital Distress Inventory (UDI) 6 score
timeFrame: Baseline up to 12 months
measure: Vaginal health index score
timeFrame: Baseline up to 12 months
measure: Vaginal caliber
timeFrame: Baseline up to 12 months
measure: Discomfort and pain during carbon dioxide fractional (CO2RE) laser treatment using the visual analog scale
timeFrame: Up to 12 months
measure: Treatment satisfaction as measured by 5-point Likert scale
timeFrame: Up to 12 months
measure: Adherence to aromatase inhibitor as measured by the Simplified Medication Adherence Questionnaire
timeFrame: Up to 12 months
measure: Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: Up to 12 months
Other outcomes:
measure: Change in vaginal cytology using vaginal maturation index
timeFrame: Baseline up to 12 months
measure: Assessment of serum estradiol levels
timeFrame: Baseline up to 12 months
Locations:
Study officials:
affiliation: Mayo Clinic
name: Saranya Chumsri
role: PRINCIPAL_INVESTIGATOR
References: