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Search / Trial NCT06059586

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Launched by INDIANA UNIVERSITY · Sep 22, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Vaginal Dilator Pelvic Health Physical Therapy

ClinConnect Summary

This clinical trial is looking at a new approach to help women who are about to start radiation therapy for certain types of cancer, including cervical, vaginal, vulvar, uterine, or anal cancer. The study will see if adding pelvic health physical therapy before radiation treatment can improve outcomes for patients. Participants will receive education on how to use a vaginal dilator, a device that can help with any discomfort during treatment, and they will fill out surveys to track their pain levels and sexual health.

To participate in this trial, you need to be a woman aged 18 or older who has been diagnosed with one of the specified cancers and is a candidate for radiation therapy. It's important that you can attend physical therapy sessions at a specific location. If you have serious medical issues, have received radiation to the pelvis before, or are pregnant or nursing, you may not be eligible. If you join the trial, you can expect support and education to help manage any potential side effects from the radiation treatment.

Gender

FEMALE

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

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Carmel, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Namita Agrawal, MD

Principal Investigator

Indiana University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported