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

Official title

The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale.

SECONDARY OBJECTIVES:

I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female.

II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale.

III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy.

OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II.

ARM I: 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.

ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (3)

• Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only) [Time frame: Baseline up to 24 months after completion of treatment]
• Change in quality of life [Time frame: Baseline up to 24 months after completion of treatment]
• Incidence of adverse events associated with vaginal fractional CO2 laser therapy [Time frame: Up to 24 months after completion of treatment]

Eligibility criteria

Inclusion criteria

• 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
• 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 salpingooophorectomy) 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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Trinity Health IHA - Obstetrics and Gynecology West Arbor — Ann Arbor
• Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT05379153 · A221801 · NCI-2022-02754 · UG1CA189823

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗