Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03666819
Status:
WITHDRAWN
Last Update Posted:
2023-01-06
First Post:
2018-09-10
Brief Title:
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Manufacturer will not be supporting this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC1892 | OTHER | Mayo Clinic in Florida | None |
| NCI-2018-01774 | REGISTRY | None | None |