Pelvic Health Therapy for Pelvic Radiotherapy Patients

Recruiting in Palo Alto (17 mi)

Overseen by Namita Agrawal, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Major illnesses, Psychiatric impairments, Prior pelvic radiation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems you can continue with prior or current treatments like surgery and chemotherapy.

What data supports the effectiveness of this treatment for pelvic health therapy in pelvic radiotherapy patients?

Research shows that using vaginal dilators and pelvic floor exercises can help prevent vaginal stenosis (narrowing) and improve sexual health and quality of life for women undergoing radiotherapy for cervical cancer. Most women in a study maintained or increased the size of the dilator they used and remained sexually active, indicating the treatment's effectiveness. ^{1 2 3 4 5}

Is pelvic health therapy safe for humans?

Vaginal dilator therapy, often used for women undergoing pelvic radiation therapy, is generally considered safe and is recommended to prevent issues like vaginal stenosis (narrowing of the vagina). Studies show high adherence and effectiveness in maintaining vaginal health, with no significant safety concerns reported. ^{1 2 3 6 7}

How is pelvic health therapy different from other treatments for pelvic radiotherapy patients?

Pelvic health therapy for pelvic radiotherapy patients is unique because it combines vaginal dilator use with pelvic floor muscle exercises to prevent vaginal stenosis (narrowing) and improve sexual health and quality of life. This approach is distinct as it emphasizes both physical rehabilitation and sexual recovery, which are not standard in all treatment protocols. ^{1 2 3 4 8}

Eligibility Criteria

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.

Inclusion Criteria

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

I am a candidate for a specific type of radiation therapy aimed at curing my pelvic cancer.

I have had or am having treatments like surgery or chemotherapy for my condition.

Exclusion Criteria

My doctor says radiation won't cure my cancer.

I have had radiation therapy to my pelvic area before.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Rehabilitation

Participants receive pre-rehabilitation pelvic health physical therapy and education on using a vaginal dilator

4 weeks

Radiation Treatment

Participants undergo standard of care radiation therapy treatment

6-8 weeks

Follow-up

Participants are monitored for adherence to dilator use and evaluated for sexual function and pain

16 weeks

Visits at 4, 6, 8, 12, and 16 weeks post radiation

Treatment Details

Interventions

• Dilator (Procedure)
• Pre-Rehabilitation (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Pelvic health Assessment and Intervention Experimental Treatment 2 Interventions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

IU Health Schwarz Cancer Center Carmel, IN

Who Is Running the Clinical Trial?

Indiana University Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. [2022] Although vaginal dilator use after combined pelvic radiation therapy and brachytherapy (RT/BT) is recommended to prevent vaginal shortening and stenosis, women fail to use them and experience sexual problems. A nurse-led sexual rehabilitation intervention targeting sexual recovery and vaginal dilatation was developed. Its feasibility was investigated during a prospective, longitudinal, observational pilot study.

2. United States pubmed.ncbi.nlm.nih.gov

Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. [2021] Guidelines for the care of women undergoing pelvic radiation therapy (RT) recommend vaginal dilator therapy (VDT) to prevent radiation-induced vaginal stenosis (VS); however, no standard protocol exists. This review seeks to update our current state of knowledge concerning VS and VDT in radiation oncology.

3. England pubmed.ncbi.nlm.nih.gov

Vaginal Dilator and Pelvic Floor Exercises for Vaginal Stenosis, Sexual Health and Quality of Life among Cervical Cancer Patients Treated with Radiation: Clinical Report. [2021] This clinical report aimed to evaluate the effectiveness of the combination of vaginal dilator (VD) and pelvic floor muscle exercises (PFME) on vaginal stenosis, sexual health and quality of life among women undergoing radiotherapy treatment for cervical cancer; PFME were instructed prior to radiotherapy with six-month follow-up. An intention-to-treat analysis was performed for the 28 women. At four-months after radiotherapy, most of the women (90.9%) maintained/increased one size of the VD and were sexually active (81.8%). Adherence to VD was high. Regarding quality of life, there was more limitation in emotional functioning. VD and PFME were effective at preventing stenosis.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. [2022] The present study aims to describe: 1. How the side effects of radiotherapy (RT) could impact sexual health in women; 2. The effectiveness of physical rehabilitation including pelvic floor muscle training (PFMT) in the management of sexual dysfunction after RT.

5. Scotland pubmed.ncbi.nlm.nih.gov

Barriers to and strategies for dealing with vaginal dilator therapy - Female pelvic cancer survivors' experiences: A qualitative study. [2023] Vaginal changes, a frequently reported late effect among women treated with pelvic radiotherapy, can result in sexual dysfunction and distress. Women are recommended vaginal dilator therapy after completed radiotherapy; however, low adoption has been recognized. This study aims to provide insight into women's difficulties with carrying out vaginal dilator therapy and their experiences of information.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. [2023] Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic radiotherapy to mitigate vaginal stenosis. Currently, the dilators given to patients by most hospitals are made of plastic, compared to silicone dilators which are available on the market for purchase.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. [2023] Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic radiotherapy to mitigate vaginal stenosis. Currently, the dilators given to patients by most hospitals are made of plastic, compared to silicone dilators which are available on the market for purchase.

8. England pubmed.ncbi.nlm.nih.gov

Sexual rehabilitation after pelvic radiotherapy and vaginal dilator use: consensus using the Delphi method. [2018] This study aimed to reach consensus among professional experts on patient information provision and support regarding sexual rehabilitation and vaginal dilator use after radiotherapy (RT) for gynecological cancers.