Vaginal CO2 laser for vaginal dryness in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase III trial that assigns participants 2:1 to receive either vaginal fractional CO2 laser therapy or a sham procedure, given three times about six weeks apart, with follow-up to 24 months. The primary outcome is change in patient-reported vaginal dryness on an 11-point (0-10) numeric scale. Secondary outcomes include patient-reported vaginal discomfort during sex (PROMIS Sexual Function), a single-item quality-of-life numeric scale, and monitoring for procedure-related toxicities. Eligible participants are women treated with curative intent for breast cancer at least 12 months earlier and may be on stable endocrine therapy.

Why it matters

Who can join: the full rules

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 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 who are receiving endocrine therapy +/- monoclonal therapy like trastuzumab and pertuzumab are eligible
* 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)

Where it's running

• Iowa Methodist Medical Center
  Des Moines, Iowa, United States Recruiting
• Trinity Health IHA - Obstetrics and Gynecology West Arbor
  Ann Arbor, Michigan, United States Recruiting
• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Suspended

Study contacts

• Study coordinator: Maryam Lustberg, MD, MPH
• Email: Maryam.lustberg@yale.edu
• Phone: (203) 785-4095

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mobile health navigation to improve breast cancer screening in Kenyan women

  This study tests m-Health patient navigation tools to help women in Kenya access breast cancer screening and early detection services.

  Recruiting Emory University · Atlanta, Georgia · NCT07764796

• Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression

  This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.

  Recruiting at 11 sites City of Hope Medical Center · Arcadia, California and 10 other locations · NCT07741968

• F-GYN injection for vaginal dryness and vaginal/vestibular atrophy

  This study tests whether a one-time F-GYN injection can relieve vaginal dryness and related symptoms in adult women with atrophic vaginitis/vestibulovaginal atrophy compared with standard non-hormonal care.

  Recruiting at 3 sites Biovico Sp. z o.o. · Bolesławice and 2 other locations · NCT07701863

• Environmental exposure checks in high-risk and early-onset breast cancer care

  This study tests how patients and providers feel about using environmental exposure risk data in breast cancer care for women at average/high risk or with early-onset breast cancer.

  Recruiting City of Hope Medical Center · Duarte, California · NCT07690852

• CSF sample collection from people with metastatic breast cancer to see brain metastasis risk

  This study tests whether spinal fluid and other samples can help predict brain metastases in adults with metastatic HER2-positive or triple-negative breast cancer who have not yet shown brain involvement.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619534

• Body composition and outcomes after breast reconstruction

  This study will see if detailed body composition measurements can help predict complications after mastectomy with immediate breast reconstruction in adult women.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07546331

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.