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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT05379153
Phase
PHASE3
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (vaginal fractional CO2 laser therapy)
    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.
  • Sham Comparator: Arm II (placebo)
    Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Changes in patient reported vaginal dryness severity [ Time Frame: Up to 18 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Trinity Health IHA - Obstetrics and Gynecology West ArborAnn ArborMichigan48103
Site Public Contact
[email protected]
Gina B. Long (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
Allison M. Quick (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
Trinity Health IHA - Obstetrics and Gynecology West Arbor· Ann Arbor, MIOhio State University Comprehensive Cancer Center· Columbus, OH

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