Breast Carcinoma Clinical Trial
Official title:
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Verified date | March 2023 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | May 5, 2022 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Vaginal Assessment Scale score | Using Vaginal Assessment Scale (VAS) | Baseline up to 4 weeks | |
Primary | Patient compliance rates | Compliance rates with treatment will be assessed. | Up to 4 weeks | |
Primary | Feasibility of laser treatments defined by completion rates and tolerability of treatment | Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics. | Up to 4 weeks | |
Secondary | Other symptoms of urogenital atrophy using the Urogenital Distress Inventory | Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemars Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary. | Up to 4 weeks | |
Secondary | Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare | Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemar?s Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary. | Up to 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Completed |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |