NCT05379153

Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial

The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale. SECONDARY OBJECTIVES: I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female. II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale. III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy. OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II. ARM I: Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.

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
• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Laser Therapy	Undergo vaginal fractional CO2 laser therapy
DEVICE	Sham Intervention	Undergo placebo procedure
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Quality of Life Assessment	Ancillary studies

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-01
• Completion: 2027-05-01
• First posted: 2022-05-18
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study