An interventional study of Laser Therapy and Questionnaire Administration in Cervical Carcinoma, Dyspareunia and Endometrial Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 4 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
Among 15 studies in Uterine Cervical Neoplasms by Ohio State University Comprehensive Cancer Center — 2 open to participants now, 4 under way, none of them phase 3. Uterine Cervical Neoplasms · Ohio State University Comprehensive Cancer Center.
Among the 15 studies in Uterine Cervical Neoplasms by Ohio State University Comprehensive Cancer Center, this one is the 11th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2018, is one of 10 with no phase, and was the 9th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →2 of the 15 studies in Uterine Cervical 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
By country, each count listing its studies:
Of the 473 Uterine Cervical Neoplasms studies recruiting now, 242 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 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.
15 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
This study's enrollment of 19 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 102 across the 12 interventional studies, 191 across the 3 observational. Of the 11 that completed or were terminated, 1 (9%) 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.
2 of the studies in Uterine Cervical 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 |
|---|---|
| NCT07407647Ohio State University Comprehensive Cancer CenterVaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer | 2026-12-31 |
| NCT04452526Ohio State University Comprehensive Cancer CenterI Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination | 2027-06-30 |
Among the 15 studies in Uterine Cervical Neoplasms by Ohio State University Comprehensive Cancer Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
PRIMARY OBJECTIVES:
I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
I. To evaluate toxicity associated with vaginal laser therapy in this population.
II. To determine how many women with the defined patient eligibility will complete all treatments.
III. To determine the feasibility of the crossover design for potential use in a phase III trial.
IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
V. To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment.
VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI).
VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized in to 1 of 2 arms.
ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
After completion of study, patients are followed up at 1 month.
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.
Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment
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 at 3 time points 30 days apart.
Procedure: Laser Therapy · Other: Questionnaire Administration
Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
Other: Questionnaire Administration · Procedure: Sham Intervention
Undergo fractional CO2 laser therapy
Also known as: Therapy, Laser
Ancillary studies
Undergo sham laser therapy
Change in genitourinary syndrome of menopause (GSM) symptoms
Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner.
Time frame: Baseline to 12 weeks
Feasibility as measured by number of patients able to complete 3 study visitis
A crossover design to determine the feasibility of the crossover design for potential use in a phase III trial by summarizing the proportion of patients who are unable to tolerate the study treatment prior to completing the 3 treatments
Time frame: Up to 1 month
Improvement in objective findings of vaginal atrophy
Will determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
Time frame: Up to 1 month
Improvement in sexual function by FSFI
Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 1 year
Improvement in sexual function FSDS
Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS)
Time frame: Up to 1 year
Improvement in urinary symptoms
Will determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI). The change in dyspareunia and dryness between baseline (T0) and T4 will be calculated and compared between the treatment and sham arms using a two sample t-test or Wilcoxon rank sum test.
Time frame: Up to 1 month
Incidence of adverse events
Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)
Time frame: Up to 1 month
Number of patients complete all treatments
Summarize the proportion of patients who are able to tolerate the study treatment and complete the 3 treatments.
Time frame: Up to 1 month
Satisfaction with vaginal fractional CO2 laser therapy
Patients will be asked to rate their satisfaction with the procedure on a likert-type scale of 1-10 with 1 being completely dissatisfied and 10 being extremely satisfied. Participants will be asked to rate their satisfaction on this scale after each treatment and at follow-up.
Time frame: Up to 1 month
Plan to share: No
Ran from May 2018 to primary completion in Dec 2019, 19 months.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 19 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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