Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT06059586

Conditions

Dyspareunia

Pelvic Pain

Sexual Dysfunction

Radiation Toxicity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic health therapy

Dilator feasability

Study Details

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.

Conditions

Dyspareunia

Pelvic Pain

Sexual Dysfunction

Radiation Toxicity

Study ID

NCT06059586

Start date

Jan 16, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pelvic health Assessment and Intervention

Interventions

Pelvic health therapy

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

Dilator feasability

Patient Adherence to Vaginal Dilation Questionnaire

Primary outcome measure

  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline ]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline ]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline ]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline ]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline to 6 weeks ]
  • Feasability of implementation of pre-rehabilitation to radiotherapy [ Time Frame: Baseline to 4 months ]

Central Contacts and Locations

Central contacts

Namita Agrawal, MD

(317)944-2524agrawaln@indiana.edu

Sarah Dutkevich, RN

(317)278-5618sdutkevi@iu.edu

Locations

IU Health West

Recruiting

Avon, Indiana, United States, 46123

Contacts

Nikki Barrow

317-944-1242nrbarrow@iu.edu

IU Health Schwarz Cancer Center

Recruiting

Carmel, Indiana, United States, 46032

Contacts

John Spittler

3172740771ajspittl@iu.edu

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sarah Dutkevitch, RN

317-278-5618sdutkevi@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • vaginal dilator
  • pelvic health physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-27.