Actively Recruiting
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Led by Indiana University · Updated on 2026-02-27
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the feasibility of adding pelvic health physical therapy before radiation treatment for women diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer who are candidates for curative pelvic external beam radiation. The study focuses on addressing side effects like pelvic pain and painful intercourse, which can affect quality of life after treatment. It seeks to understand challenges and benefits of coordinating pelvic health therapy with standard radiation care. Participants will receive education on using a vaginal dilator, a device designed to help maintain vaginal canal openness and stretch pelvic floor muscles, during their radiation treatment. The study combines pelvic health therapy involving assessments and vaginal dilator education with standard radiation therapy, delivered in collaboration between physical therapists and radiation oncology staff. Treatment includes physical therapy evaluations, questionnaires, and ongoing support throughout the radiation period. During the study, participants will complete questionnaires on pain and sexual function at various points including immediately after radiation and up to 16 weeks post-treatment. Researchers will monitor adherence to vaginal dilator use and assess pelvic pain using a pain rating scale. The main outcome is to evaluate the feasibility of this pre-rehabilitation approach alongside radiation therapy. The total participation duration covers baseline through several follow-up assessments over months after radiation.
CONDITIONS
Brief Title
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- 18 years old or older at the time of informed consent
- Able to provide written informed consent and HIPAA authorization
- Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- Candidate for curative pelvic radiation with external beam, with or without brachytherapy
- May have prior or current treatment including surgery and chemotherapy
- Able to attend physical therapy visits at IUH North/Schwarz Cancer Center
You will not qualify if you...
- Major medical illnesses or psychiatric conditions that would prevent therapy or follow-up
- Not a candidate for curative radiation therapy
- Prior radiation therapy to the pelvis
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to radiotherapy start
Participants receive pelvic health therapy including physical therapy evaluation, pelvic floor muscle examination, and vaginal dilator education before starting pelvic radiotherapy.
Multiple outpatient visits before radiation therapy
Duration - Varies according to radiation schedule
Participants undergo curative pelvic radiation therapy with external beam, with or without brachytherapy.
Radiotherapy visits as scheduled by oncology team
Duration - Up to 16 weeks post radiation
Participants are monitored for pelvic pain, sexual function, and adherence to vaginal dilator use after completing radiation therapy.
Follow-up visits at radiation completion and at 4, 6, 8, 12, and 16 weeks post radiation
Trial Site Locations
Total: 3 locations
1
IU Health West
Avon, Indiana, United States, 46123
Actively Recruiting
2
IU Health Schwarz Cancer Center
Carmel, Indiana, United States, 46032
Actively Recruiting
3
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
N
Namita Agrawal, MD
S
Sarah Dutkevich, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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