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

NCT05379153 | Recruiting Phase 3 DMC FDA Device

• 3 other identifiers: A221801NCI-2022-02754UG1CA189823
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Vaginal Atrophy; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Changes in patient reported vaginal dryness severity

  Will use an 11-point (0-10) 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.

  Up to 18 weeks

Secondary Outcomes (3)

• Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only)

  Baseline up to 24 months after completion of treatment

• Change in quality of life

  Baseline up to 24 months after completion of treatment

• Incidence of adverse events associated with vaginal fractional CO2 laser therapy

  Up to 24 months after completion of treatment

Study Arms (2)

Arm I (vaginal fractional CO2 laser therapy)

EXPERIMENTAL

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.

Device: Laser Therapy; Other: Questionnaire Administration; Other: Quality of Life Assessment

Arm II (placebo)

SHAM COMPARATOR

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

Device: Sham Intervention; Other: Questionnaire Administration; Other: Quality of Life Assessment

Interventions

Laser Therapy DEVICE

Undergo vaginal fractional CO2 laser therapy

Arm I (vaginal fractional CO2 laser therapy)

Sham Intervention DEVICE

Undergo placebo procedure

Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (vaginal fractional CO2 laser therapy); Arm II (placebo)

Quality of Life Assessment OTHER

Ancillary studies

Arm I (vaginal fractional CO2 laser therapy); Arm II (placebo)

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Ann Arbor, Michigan, 48103, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Maryam Lustberg, MD, MPH

  Yale University Comprehensive Cancer Center

  STUDY CHAIR

Central Study Contacts

Maryam Lustberg, MD, MPH

CONTACT

(203) 785-4095; Maryam.lustberg@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The provider will not be blinded to the arm the patient is on. PRO measures will be administered by research personnel who are blinded to the arm the patient is enrolled on at each study time point.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 18, 2022
• Study Start: April 21, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (2)