[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07447895":3,"trial-entities:NCT07447895":91,"trial-summary:NCT07447895":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":83,"overall_officials":88,"references":89,"see_also_links":90},"NCT07447895","UCCC-RT-25-05","Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies","RECRUITING","2030-04-16","2026-04","2026-04-23","2026-04-16","University of Cincinnati","OTHER",true,"This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.","This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. The objective is to determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.",[18,19,20],"Cervical Cancer","Radiation Therapy Complication","Pelvic Floor Disorders",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},28,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Pelvic floor physical therapy","Four weeks after completion of RT, patients will begin a standardized pelvic floor PT course. The protocol will include two 1-hour physical therapy appointments focused on pelvic floor muscle training, dilator training and education. These sessions will be 4 weeks apart and performed by a pelvic floor physical therapist.",[32],[36],{"measure":37,"description":38,"timeFrame":39},"Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey","To determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\nThe primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.","3 months after Radiation Therapy Treatment",[41,44,47,50,53],{"measure":42,"description":43,"timeFrame":39},"Rates of urinary incontinence via EORTC-QLQ CX24","1\\. To determine the rates of urinary incontinence 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\na. Secondary endpoints will include rates of urinary incontinence as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.",{"measure":45,"description":46,"timeFrame":39},"Sexual symptoms via EORTC-QLQ CX24","1\\. To determine sexual symptoms at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\na. Secondary endpoints will include rates of sexual symptoms as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.",{"measure":48,"description":49,"timeFrame":39},"QOL as obtained from the EORTC-QLQ CX24","1\\. To determine QOL at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\na. Secondary endpoints will include QOL as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.",{"measure":51,"description":52,"timeFrame":39},"Compliance rates with recommended standard of care schedule of dilator via self reports","2\\. To determine compliance rates with recommended standard of care schedule of dilator use at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\n1. Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage.\n2. Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation",{"measure":54,"description":55,"timeFrame":56},"Evaluate changes in pelvic floor muscle function using the validated Brink scale","3\\. To evaluate changes in pelvic floor muscle function at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.\n\na. Descriptive analysis of pelvic floor muscle function (strength, coordination, endurance objectively graded using the validated Brink scale) at baseline and follow up, along with participant reported compliance with home exercise course will also be collected and reported.","At Baseline and at 3 months after Radiation Therapy Treatment","FEMALE","18 Years",null,false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Participants must be female.\n2. Patients must be 18 years old or older.\n3. Any patient with invasive cervical cancer who is planned for definitive chemoradiation.\n4. Plan to receive a minimum dose of 45Gy to pelvis per investigator.\n5. Willing to undergo pelvic floor physical therapy.\n\nExclusion Criteria:\n\n1. Any previous therapeutic pelvic radiation.\n2. Non-English speaking.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":12,"status":7,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"Cincinnati","Ohio","45219","United States",[75,78],{"name":76,"role":77},"UCCC Clinical Trials Office","CONTACT",{"name":79,"role":77},"Sarah Sittenfeld",{"lat":81,"lon":82},39.12711,-84.51439,[84,87],{"name":76,"role":77,"phone":85,"email":86},"513-584-7698","cancer@uchealth.com",{"name":79,"role":77},[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Cervical Carcinoma",[],{"nct_id":4,"found":14,"summary":96,"prompt_version":106},{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is a single-arm study, meaning all 28 participants will receive the same treatment. It is a Phase II study.","completed","Pelvic Floor Physical Therapy for Cervical Cancer Patients Receiving Radiation","This study is looking at whether early pelvic floor physical therapy can help women with cervical cancer who are receiving radiation treatment. You might be able to join if you are a woman aged 18 or older with invasive cervical cancer, are planning to receive a specific dose of pelvic radiation, and are willing to do pelvic floor physical therapy. The study will test if this therapy can reduce fecal incontinence (accidental bowel leakage) three months after radiation therapy. This study is currently unclear on its recruitment status and plans to enroll 28 participants.","Your fecal incontinence will be evaluated at 3 months after your radiation therapy treatment.",94,"You would begin a standardized pelvic floor physical therapy course four weeks after completing radiation therapy. This involves two 1-hour physical therapy appointments focusing on muscle training, dilator training, and education.","Not stated in the trial record.",[32],"v2"]