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Pelvic Health Therapy for Pelvic Radiotherapy Patients

N/A

Recruiting

Led By Namita Agrawal, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer

≥ 18 years old at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months

Awards & highlights

Study Summary

This trial will explore if pelvic health PT can help women with pelvic cancer during radiation treatment. They'll get education and answer questions on pain & sexual function.

Who is the study for?

This trial is for women over 18 with cervical, vaginal, vulvar, uterine, or anal cancer who are set to undergo curative pelvic radiation. They must be able to attend physical therapy at a specific center and can have had surgery or chemo. It's not for those with major illnesses/psychiatric issues that affect participation, pregnant/nursing women, or those previously treated with pelvic radiation.Check my eligibility

What is being tested?

The study tests if adding pre-rehabilitation pelvic health physical therapy before standard radiation treatment helps female patients. It includes education on using a vaginal dilator during treatment and evaluates pain and sexual function through questionnaires.See study design

What are the potential side effects?

While the trial itself doesn't involve drugs that typically cause side effects, participants may experience discomfort from the use of vaginal dilators and potential emotional distress from discussing intimate aspects of their health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My primary cancer diagnosis is in the cervix, vagina, vulva, uterus, or anus.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasability of implementation of pre-rehabilitation to radiotherapy

Secondary outcome measures

Average score on the Visual Pain Rating Scale.

Evaluate female sexual function based on questionnaire responses

Percentage of adherence to dilator use

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pelvic health Assessment and InterventionExperimental Treatment2 Interventions

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,742 Total Patients Enrolled

Namita Agrawal, MDPrincipal InvestigatorIndiana University

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research initiative currently have any openings for participants?

"Unfortunately, the details on clinicaltrials.gov suggest that this trial is not presently enlisting volunteers. The initial post was published October 1st 2023 and last edited October 3rd 2023; however, there are 90 other studies actively recruiting as of today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Namita Agrawal 2024. "Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059586.

All > Dyspareunia > Indianapolis