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

ConditionsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Vaginal Atrophy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age22+
SponsorAlliance for Clinical Trials in Oncology

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Laser Therapy

    Device

    Undergo vaginal fractional CO2 laser therapy

  • Sham Intervention

    Device

    Undergo placebo procedure

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Quality of Life Assessment

    Other intervention

    Ancillary studies

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Arm I (vaginal fractional CO2 laser therapy)Experimental treatment 3 interventions
Group B: Arm II (placebo)Sham comparator 3 interventions

Trial outcomes

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.

Time frame
Up to 18 weeks

Secondary outcomes

1

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

Assessed using the Vaginal discomfort domain of Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (V) 2.0 Brief Profile - Female (only the sexually active women will be evaluable for this, which is estimated to be approximately 50% of the population). Higher scores represent more discomfort (1: None - 5: A lot). Change in the vaginal discomfort domain of the PROMIS Sexual Function v. 2.0 Brief Profile-Female from baseline to each post-therapy-initiation time point will be summarized by treatment arm and will be compared as described for the primary endpoint.

Time frame
Baseline up to 24 months after completion of treatment
2

Change in quality of life

Evaluated using 11-point (0-10) numerical analog scale. Higher scores represent better quality of life (0: As bad as it can be - 10: As good as it can be). Change in patient reported quality of life from baseline to each post-therapy initiation time point will be summarized and compared as described for the primary endpoint.

Time frame
Baseline up to 24 months after completion of treatment
3

Incidence of adverse events associated with vaginal fractional CO2 laser therapy

Incidences of toxicities in the fractional CO2 laser therapy arm will be summarized by type. Common toxicities that occur in both arms will be summarized and compared between arms using the Chi-square test or Fisher's exact test, as appropriate.

Time frame
Up to 24 months after completion of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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