About this trial

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.

Eligibility criteria

Qualifiers

Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and/or radiation) >= 12 months prior to registration. Concurrent trastuzumab /pertuzumab is permissible

May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +/- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant endocrine therapy prior to registration must 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 aromatase inhibitor (AI) therapy, tamoxifen with or without ovarian function suppression therapy must have been on their current endocrine therapy regimen for at least 6 months prior to registration

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 evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Laser Therapy
  • Sham Intervention
  • Questionnaire Administration
  • Quality of Life Assessment

Treatment groups

250 Participants
are divided into 2 treatment groups

Locations

2
Trinity Health IHA - Obstetrics and Gynecology West Arbor48103, Ann ArborMichigan, United States
Ohio State University Comprehensive Cancer Center43210, ColumbusOhio, United States

Sponsors and collaborators

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator