Pre-rehabilitation for women receiving pelvic radiation therapy
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
This study is testing if adding pelvic health physical therapy to radiation treatment can help women with certain cancers feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Avon, Indiana and 2 other locations) |
| Trial ID | NCT06059586 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of incorporating pelvic health physical therapy into the standard radiation treatment plan for women diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer. Participants will receive education on the use of vaginal dilators and complete questionnaires assessing pain and sexual function. The study focuses on identifying barriers and facilitators to implementing this pre-rehabilitation service and its potential clinical value in reducing pelvic pain and dyspareunia. By collaborating with radiation oncology staff, the study seeks to improve the quality of life for patients undergoing pelvic radiation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer who are candidates for curative pelvic radiation.
Not a fit: Patients who are not candidates for curative radiation therapy or have prior pelvic radiation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pelvic pain and sexual dysfunction in women undergoing pelvic radiation therapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in addressing post-treatment side effects in cancer patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Avon, Indiana and 2 other locations
- IU Health West — Avon, Indiana, United States (Recruiting)
- IU Health Schwarz Cancer Center — Carmel, Indiana, United States (Recruiting)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Namita Agrawal, MD — Indiana University
- Study coordinator: Namita Agrawal, MD
- Email: agrawaln@indiana.edu
- Phone: (317)944-2524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.