Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Study on Preparation Therapy for Women Undergoing Pelvic Radiotherapy

N
Namita Agrawal

Primary Investigator

Recruiting
18 years or above
Female
Phase N/A
20 participants needed
1 Location

Brief description of study

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.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Behavioral: Pelvic health therapy

  • Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education

Device: Dilator feasability

  • Patient Adherence to Vaginal Dilation Questionnaire

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicitycervical, Vaginal cancer, Vulvar cancer, Uterine cancer, Anal cancer
  • Age: 18 years or above
  • Gender: Female

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

This study investigates the feasibility of adding pre-rehabilitation pelvic health physical therapy to the standard radiation treatment plan for women with certain types of cancer. These include cervical, vaginal, vulvar, uterine, or anal cancer. Participants will receive education on using a vaginal dilator during their treatment. The study will also involve completing questionnaires about pain and sexual function to better understand the therapy's impact.

Participants will undergo pelvic health therapy, which includes a physical therapy evaluation and pelvic floor muscle examination. They will be educated on how to use a vaginal dilator, and their adherence to this practice will be monitored through a questionnaire. The study will use tools like the Female Sexual Function Index and VAS Pain Scale to evaluate the therapy's effects.

  • Who can participate: Women aged 18 and older with a primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer, who are candidates for curative pelvic radiation and able to attend physical therapy visits at IUH North/Schwarz Cancer Center, may participate.
  • Study details: Participants will engage in pelvic health therapy, which includes a physical therapy evaluation and education on using a vaginal dilator. They will complete questionnaires to assess their experience and adherence to the therapy.
Updated on 13 Oct 2025. Study ID: CTO-IUSCCC-0772, 19190

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