Breast CarcinomaNCT03307044
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
A study testing Laser Therapy and Questionnaire Administration in people with Breast Carcinoma and Cancer Survivor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Carcinoma, Cancer Survivor, Cervical Carcinoma
- What is being tested?
- Laser Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment.
II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
- Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS).
II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).
III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale (PGI-I).
OUTLINE:
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
After completion of study treatment, patients are followed up at 4 weeks.
- Being tested
- Laser Therapy, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyProcedure or surgery
Also called Therapy, Laser
Undergo fractional CO2 laser therapy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (fractional CO2 laser therapy) | Experimental | Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments. Receives: Procedure: Laser Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Assessment Scale score
Using Vaginal Assessment Scale (VAS)
Measured: Baseline up to 4 weeks
Patient compliance rates
Compliance rates with treatment will be assessed.
Measured: Up to 4 weeks
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.
Measured: Up to 4 weeks
Secondary outcomes (2)
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.
Measured: Up to 4 weeks
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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start16 Nov 2017
- Primary completion21 Dec 2018
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Quick, Ohio State University Comprehensive Cancer Center
- Investigators
- Allison Quick, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307044
- Sponsor's protocol ID
- OSU-17153
- Other IDs
- NCI-2017-01554
- Status last verified
- Mar 2023
- First submitted
- 31 Aug 2017
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
- ClinicalTrials.gov ID
- NCT03307044
- Acronym / sponsor ID
- OSU-17153
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment.
II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
- Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS).
II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).
III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale (PGI-I).
OUTLINE:
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
After completion of study treatment, patients are followed up at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (fractional CO2 laser therapy) | Experimental | Procedure: Laser Therapy, Other: Questionnaire AdministrationPatients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyAlso: Therapy, LaserUndergo fractional CO2 laser therapy | Procedure or surgery | Treatment (fractional CO2 laser therapy) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (fractional CO2 laser therapy) |
Primary outcome
Change in Vaginal Assessment Scale score
Time frame: Baseline up to 4 weeks
Using Vaginal Assessment Scale (VAS)
Patient compliance rates
Time frame: Up to 4 weeks
Compliance rates with treatment will be assessed.
Feasibility of laser treatments defined by completion rates and tolerability of treatment
Time frame: Up to 4 weeks
Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.
2 secondary outcomes
Other symptoms of urogenital atrophy using the Urogenital Distress Inventory
Time frame: Up to 4 weeks
Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Quick, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Questionnaire Administration in people with Breast Carcinoma and Cancer Survivor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal Assessment Scale score (time frame: Baseline up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.