Status:
RECRUITING
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
Lead Sponsor:
Indiana University
Conditions:
Dyspareunia
Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
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 be...
Detailed Description
Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects ha...
Eligibility Criteria
Inclusion
- Female
- ≥ 18 years old at the time of informed consent
- Ability 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, 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
- 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.
- Not a candidate for curative radiation therapy per radiation oncologist's discretion
- Prior radiation therapy to the pelvis
- Women who are pregnant or nursing
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06059586
Start Date
January 16 2024
End Date
January 1 2026
Last Update
November 12 2025
Active Locations (2)
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1
IU Health West
Avon, Indiana, United States, 46123
2
IU Health Schwarz Cancer Center
Carmel, Indiana, United States, 46032