Laser Therapy for Vaginal Dryness in Breast Cancer Survivors

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

Recruiting Phase 3 Interventional Study
Vaginal Atrophy Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
250 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for

This trial is looking for women who have had breast cancer and are experiencing vaginal dryness. Participants will undergo a laser treatment to help with their symptoms after completing their breast cancer treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a history of breast cancer treated with curative intent.
  • I have vaginal dryness that has been bothersome for at least 3 months.
  • I am at least 22 years old.
  • I am postmenopausal.
  • I can read and understand English or Spanish.
  • I have an ECOG performance status of 0 or 1.

You may not be able to join if

  • I have had any type of gynecologic cancer.
  • I have a history of certain connective tissue diseases.
  • I have had pelvic surgery involving a vaginal incision in the last 6 months.
  • I have used vaginal estrogen or similar therapies in the last 6 weeks.
  • I have had any vaginal laser treatment in the past.
  • I have ongoing invasive cancer or malignancy.
  • I have medical issues like keloid formation or thin recto-vaginal septum.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be to…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 endocri…
Contacts

Maryam Lustberg, MD, MPH

(203) 785-4095

Maryam.lustberg@yale.edu

CONTACT