An interventional study of Laser Therapy and Questionnaire Administration in Breast Carcinoma, Cancer Survivor and Cervical Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
Among 65 studies in Breast Neoplasms by Ohio State University Comprehensive Cancer Center — 12 open to participants now, 17 under way, none of them phase 3. Breast Neoplasms · Ohio State University Comprehensive Cancer Center.
Among the 65 studies in Breast Neoplasms by Ohio State University Comprehensive Cancer Center, this one is the 19th largest by enrollment of the 51 interventional ones that give a count, is one of 5 that started in 2017, is one of 29 with no phase, and was the 31st registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →12 of the 65 studies in Breast Neoplasms by Ohio State University Comprehensive Cancer Center are open now, in 1 country. Recruiting first, the newest first:
Ohio State University Comprehensive Cancer Center · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 16 · Phase 3 2
First in 1994; this study’s year is marked. 5 started in 2017.
This study's enrollment of 66 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 52 across the 51 interventional studies, 62 across the 13 observational. Of the 43 that completed or were terminated, 11 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
5 of the studies in Breast Neoplasms by Ohio State University Comprehensive Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07447700Ohio State University Comprehensive Cancer CenterA Pilot Study to Evaluate the Effectiveness of Focused Massage on Pain, Mobility, and Quality of Life During Radiation Treatment for Patients With Breast Cancer | 2026-12-30 |
| NCT07227038Ohio State University Comprehensive Cancer CenterLiving Well With Advanced Breast Cancer | 2026-12-31 |
| NCT07341503Ohio State University Comprehensive Cancer CenterThe Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients | 2026-12-31 |
| NCT06950008Ohio State University Comprehensive Cancer CenterA Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer | 2027-01-31 |
| NCT05984888Ohio State University Comprehensive Cancer CenterPilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer | 2027-06 |
Among the 65 studies in Breast Neoplasms by Ohio State University Comprehensive Cancer Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
Procedure: Laser Therapy · Other: Questionnaire Administration
Undergo fractional CO2 laser therapy
Also known as: Therapy, Laser
Ancillary studies
Change in Vaginal Assessment Scale score
Using Vaginal Assessment Scale (VAS)
Time frame: Baseline up to 4 weeks
Patient compliance rates
Compliance rates with treatment will be assessed.
Time frame: 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.
Time frame: Up to 4 weeks
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.
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
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.
Time frame: Up to 4 weeks
Plan to share: No
Ran from Nov 2017 to primary completion in Dec 2018, 13 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 13 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University Comprehensive Cancer Center →