NCT06059586 Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
| NCT ID | NCT06059586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Dyspareunia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-01-16 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
Eligibility Criteria
Inclusion Criteria: 1. Female 2. ≥ 18 years old at the time of informed consent 3. Ability to provide written informed consent and HIPAA authorization 4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer 5. Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion Notes: * Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy * Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center Exclusion Criteria: 1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up. 2. Not a candidate for curative radiation therapy per radiation oncologist's discretion 3. Prior radiation therapy to the pelvis 4. Women who are pregnant or nursing
Contact & Investigator
Namita Agrawal, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06059586 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Dyspareunia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059586 currently recruiting?
Yes, NCT06059586 is actively recruiting participants. Contact the research team at agrawaln@indiana.edu for enrollment information.
Where is the NCT06059586 trial being conducted?
This trial is being conducted at Avon, United States, Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT06059586 clinical trial?
NCT06059586 is sponsored by Indiana University. The principal investigator is Namita Agrawal, MD at Indiana University. The trial plans to enroll 20 participants.