NCT04517370

Brief Summary

Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2023

Enrollment Period

4.4 years

First QC Date

August 16, 2020

Last Update Submit

March 10, 2024

Conditions

Breast CancerGenitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

  • Change in dryness

    Change in VAS before and after completion of treatment for dryness

    Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.

  • Change in dyspareunia

    Change in VAS before and after completion of treatment for dyspareunia

    Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.

Study Arms (2)

Laser treatment

ACTIVE COMPARATOR

Each patient will be treated once every 20-40 days, for a total of 3 laser treatments. In every visit during the study, patients will undergo gynecological examination and will complete questionnaires evaluating GSM symptoms, using a visual analogue scale (VAS) for each symptom (vaginal dryness, dyspareunia, discharge, itching and/or stinging, vaginal bleeding and dysuria) as well as treatment induced pain and side effects.

Device: Fractional/Pixel CO2 laser

Sham treatment

SHAM COMPARATOR

Each patient will be treated once every 20-40 days, for a total of 3 Sham treatments, in a similar procedure not using an active laser energy. Patients will be assessed in a similar manner. Following 3 Sham-treatments patients in the placebo group will be offered the laser treatment in an open-label study .

Device: Fractional/Pixel CO2 laser

Interventions

Fractional/Pixel CO2 laserDEVICE

The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse). Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation).

Laser treatmentSham treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with breast cancer
  • Menopause: spontaneous, surgical or chemotherapy induced
  • One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria
  • On exam, clinical findings of atrophy: thin, dry, pale vagina
  • Age\>18
  • Normal Pap smear within 3 years

You may not qualify if:

  • Menstruation
  • Chemotherapy
  • Vaginal bleeding which did not underwent evaluation
  • Concurrent treatment with topical estrogen
  • Previous vulvar, vaginal or cervical dysplasia\\ cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahinoam Lev-Sagie

Lapid, 73133, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ahinoam Lev-Sagie, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

February 1, 2019

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

March 12, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)