Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT03666819
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
A Phase 2 study testing Carbon Dioxide Fractional Laser and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Carbon Dioxide Fractional Laser and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2018to 10 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the reduction in Vulvovaginal Symptom Questionnaire (VSQ) score at 3-month follow up after CO2RE laser treatment.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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.
- 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
- Being tested
- Carbon Dioxide Fractional Laser, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Dioxide Fractional LaserDevice
Also called CO2 Fractional Laser
Undergo CO2RE laser therapy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (carbon dioxide fractional laser) | Experimental | 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. Receives: Device: Carbon Dioxide Fractional Laser; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 3 months
Secondary outcomes (9)
Reduction in VSQ score (symptoms, emotions, and life-impact)
Will evaluate the sum of first three scales of the VSQ (symptoms, emotions, and life impact), VSQ total scale, and sub-scales. Descriptive statistics (mean, SD, median, IQR) and longitudinal plots (raw value, change, change in percentage) will be used to summarize the sum of VSQ total score first three scales of the VSQ (symptoms, emotions, and life-impact), VSQ total scale and subscales.
Measured: Baseline up to 12 months
Female Sexual Function Index (FSFI) score
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize FSFI total score and subscales before and after treatment.
Measured: Baseline up to 12 months
Urogenital Distress Inventory (UDI) 6 score
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize UDI-6 score before and after treatment.
Measured: Baseline up to 12 months
Vaginal health index score
Descriptive statistics (frequency table) and histogram will be used to summarize vaginal health index score before and after treatment.
Measured: Baseline up to 12 months
Vaginal caliber
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize vaginal caliber before and after treatment.
Measured: Baseline up to 12 months
Discomfort and pain during carbon dioxide fractional (CO2RE) laser treatment using the visual analog scale
Descriptive statistics (mean, SD, median, IQR) and will be used to summarize the visual analogue pain scale during treatment.
Measured: Up to 12 months
Treatment satisfaction as measured by 5-point Likert scale
Descriptive statistics (frequency table) and histogram will be used to summarize treatment satisfaction after CO2RE laser treatment using 5-point Likert scale during follow-up
Measured: Up to 12 months
Adherence to aromatase inhibitor as measured by the Simplified Medication Adherence Questionnaire
Descriptive statistics (frequency table) and histogram will be used to summarize the Simplified Medication Adherence Questionnaire during follow-up.
Measured: Up to 12 months
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start10 Sep 2018 (estimated)
- Primary completion10 Sep 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Why it stopped: Manufacturer will not be supporting this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666819
- Sponsor's protocol ID
- MC1892
- Other IDs
- NCI-2018-01774, MC1892
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2018
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666819
- Acronym / sponsor ID
- MC1892
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer will not be supporting this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2018 (estimated)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the reduction in Vulvovaginal Symptom Questionnaire (VSQ) score at 3-month follow up after CO2RE laser treatment.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (carbon dioxide fractional laser) | Experimental | Device: Carbon Dioxide Fractional Laser, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Dioxide Fractional LaserAlso: CO2 Fractional LaserUndergo CO2RE laser therapy | Device | Treatment (carbon dioxide fractional laser) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (carbon dioxide fractional laser) |
Primary outcome
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
Time frame: Baseline up to 3 months
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.
9 secondary outcomes
Reduction in VSQ score (symptoms, emotions, and life-impact)
Time frame: Baseline up to 12 months
Female Sexual Function Index (FSFI) score
Time frame: Baseline up to 12 months
Urogenital Distress Inventory (UDI) 6 score
Time frame: Baseline up to 12 months
Vaginal health index score
Time frame: Baseline up to 12 months
Vaginal caliber
Time frame: Baseline up to 12 months
Discomfort and pain during carbon dioxide fractional (CO2RE) laser treatment using the visual analog scale
Time frame: Up to 12 months
Treatment satisfaction as measured by 5-point Likert scale
Time frame: Up to 12 months
Adherence to aromatase inhibitor as measured by the Simplified Medication Adherence Questionnaire
Time frame: Up to 12 months
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
Related trials for Anatomic Stage 0 Breast Cancer AJCC v8
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Not yet recruiting
De-escalation of Axillary Dissection for Node-positive Breast Cancer
Breast Cancer by AJCC V8 Anatomic Stage, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saranya Chumsri principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbon Dioxide Fractional Laser and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact) (time frame: Baseline up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.