RECRUITING Not applicable ClinicalTrials.gov

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT06059586

Registry updated: 2026-09-18

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Description

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.

Interventions

Pelvic health therapy (Behavioral)
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
Dilator feasability (Device)
Patient Adherence to Vaginal Dilation Questionnaire

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

Conditions

Dyspareunia Pelvic Pain Sexual Dysfunction Radiation Toxicity

Locations

IU Health West — Avon, Indiana, United States
IU Health Schwarz Cancer Center — Carmel, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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