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Testing Laser Therapy for Vaginal Dryness in Breast Cancer Survivors

This study, called The Revitalize Trial, is testing whether vaginal fractional CO2 laser therapy can help treat vaginal dryness in women who have survived breast cancer. Vaginal dryness can be a side effect of breast cancer treatments like chemotherapy or hormone therapies (such as tamoxifen or aromatase inhibitors). The study aims to see if this laser treatment is better than a placebo (a sham procedure) at reducing how severe vaginal dryness is, based on what patients report. You may be able to join if you are a woman aged 22 or older, have a history of breast cancer treated with curative intent, and finished your main treatments at least 12 months ago. The study plans to enroll 250 participants.

Study design
This study is interventional and will randomly assign participants to receive either vaginal fractional CO2 laser therapy or a placebo procedure. It will enroll 250 participants.
What's involved
You would receive three treatments, each lasting 20-30 minutes, given every 6 weeks. You would also complete questionnaires and quality of life assessments.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in vaginal dryness severity for up to 18 weeks after treatment.

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NCT05379153

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

Recruiting
PHASE3Ages 22+InterventionalSupportive care
Alliance for Clinical Trials in Oncology
~250 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Laser TherapySham InterventionQuestionnaire AdministrationQuality of Life Assessment

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in patient reported vaginal dryness severity
Measured over Up to 18 weeks

Conditions

Vaginal Atrophy
Breast Carcinoma

Explore related trials

Breast CarcinomaVaginal Atrophy

Where it's being run

2 sites across 2 states
Michigan1
Ohio1

Study leadership

  • Maryam Lustberg, MD, MPH · STUDY_CHAIR · Yale University Comprehensive Cancer Center

Who to contact

Maryam Lustberg, MD, MPH
[email protected]
(203) 785-4095
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation) within 3 months prior to registration.
Breast cancer survivors not currently on therapy are eligible
Patients may be receiving ongoing endocrine therapy These patients must be receiving adjuvant endocrine therapy prior to registration and intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist.
Patients on targeted therapy such as CD4/6 inhibitors are not eligible. Patients receiving concurrent chemotherapy and immunotherapy are not eligible.
Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \>= 4 on a 0-10-point scale that has been bothersome for \>= 3 months and for which the patient wants to undergo the study procedure
No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible
No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis
No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingo-oophorectomy) are eligible
No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and/or androgen therapy within 6 weeks prior to registration
No other suspected contraindications for undergoing laser therapy
No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible
No known concurrent invasive carcinoma/malignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment
Postmenopausal based on at least one of the following criteria at the time of registration:
Women 50 or older with no spontaneous regular menses \> 12 months
On ovarian suppression (i.e., gonadotrophin releasing hormone \[GNRH\] agonist/antagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks
Bilateral oophorectomy
Women on aromatase-inhibitor (AI) therapy (i.e., clinically judged to be postmenopausal)
In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish
Age \>= 22 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \< 2 cm between the vaginal opening and the anal opening)

What this trial measures

  • Changes in patient reported vaginal dryness severityUp to 18 weeks

    Will use an 11-point (0-10 scale) numerical analog scale to assess patient reported severity of vaginal dryness. Higher scores represent worse symptoms (0: None - 10: Worst possible). The vaginal dryness scores at each time point will be summarized separately by treatment arm using the mean (standard deviation) and median (range). The score changes from baseline to the 18-week time point (T4) will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate.