Clinical trial · Interventional
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
NCT03307044CI-TRIAL-00064819completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cancer Survivor | — | UNRESOLVED | — |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Dyspareunia | — | UNRESOLVED | — |
| Vaginal Dryness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Therapy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (fractional CO2 laser therapy)
- description
- Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
- interventionNames
- Procedure: Laser Therapy
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Change in Vaginal Assessment Scale score
- timeFrame
- Baseline up to 4 weeks
- description
- Using Vaginal Assessment Scale (VAS)
- measure
- Patient compliance rates
- timeFrame
- Up to 4 weeks
- description
- Compliance rates with treatment will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation * Symptoms of urogenital atrophy including dyspareunia or vaginal dryness Exclusion Criteria: * Patients with metastatic breast cancer * Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam) * Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility) * Pelvic organ prolapse greater than stage II * Prior reconstructive pelvic surgery involving mesh * Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.