Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

NCT ID: NCT06059586

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2026-01-31

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 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.

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 have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.

The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?

Conditions

Dyspareunia; Pelvic Pain; Sexual Dysfunction; Radiation Toxicity

Keywords

vaginal dilator; pelvic health physical therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pelvic health Assessment and Intervention

Group Type: EXPERIMENTAL

Pelvic health therapy

Intervention Type: BEHAVIORAL

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

Dilator feasability

Intervention Type: DEVICE

Patient Adherence to Vaginal Dilation Questionnaire

Interventions

Pelvic health therapy

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

Intervention Type: BEHAVIORAL

Dilator feasability

Patient Adherence to Vaginal Dilation Questionnaire

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Namita Agrawal

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Namita Agrawal, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

IU Health West

Avon, Indiana, United States

Site Status: RECRUITING

IU Health Schwarz Cancer Center

Carmel, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Namita Agrawal, MD

Role: CONTACT

Phone: (317)944-2524

Email: agrawaln@indiana.edu

Sarah Dutkevich, RN

Role: CONTACT

Phone: (317)278-5618

Email: sdutkevi@iu.edu

Facility Contacts

Nikki Barrow

Role: primary

John Spittler

Role: primary

Other Identifiers

CTO-IUSCCC-0772

Identifier Type: -

Identifier Source: org_study_id