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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

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Status Withdrawn

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• 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
• Atrophy
• Breast Adenocarcinoma
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

• NCT number: NCT03666819
• Study type: Interventional
• Source: Mayo Clinic
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 10, 2018
• Completion date: September 10, 2021