Pelvic Health Therapy for Pelvic Radiotherapy Patients

Recruiting at 1 trial location

Overseen By Sarah Dutkevich, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding pelvic health physical therapy before radiation treatment can help women with certain pelvic cancers, such as cervical or uterine cancer, manage pain and improve sexual function. Participants will learn to use a vaginal dilator, a device that gently stretches vaginal tissues, during treatment and will complete surveys about their pain and sexual health. Women diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer who are set to receive radiation therapy may be eligible to join. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance the quality of life for future patients.

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 prior data suggests that pre-rehabilitation pelvic health physical therapy and vaginal dilator use are safe for pelvic radiotherapy patients?

Research shows that patients generally find using a vaginal dilator as part of pelvic rehabilitation easy to handle. One study examined how vaginal dilators can reduce vaginal narrowing caused by radiation and improve sexual health. This study found no major safety issues with using dilators during radiation treatment.

Regarding pelvic physical therapy before treatment, studies have indicated it can enhance quality of life. It may help manage pelvic pain and prevent issues like loss of bladder control, suggesting that therapy before treatment is also well-tolerated.

Overall, both the vaginal dilator and pre-treatment therapy have proven safe and manageable for patients undergoing pelvic radiation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for pelvic health in patients undergoing pelvic radiotherapy because they offer a proactive approach to preventing complications. Unlike traditional treatments that often address issues after they arise, pre-rehabilitation aims to strengthen and prepare pelvic muscles before radiotherapy begins, potentially reducing the severity of side effects. Meanwhile, the use of dilators as part of pelvic health therapy can help maintain flexibility and function, which is a step forward in preserving quality of life. This proactive, dual-approach is innovative in its focus on prevention and maintenance rather than just treatment after the fact.

What evidence suggests that this trial's treatments could be effective for pelvic health in pelvic radiotherapy patients?

Research has shown that vaginal dilators can help prevent vaginal stenosis, a narrowing of the vagina that can occur after pelvic radiation therapy. This therapy may also improve sexual health and quality of life for some women. However, strong evidence does not support the regular use of dilators during radiation treatment to prevent stenosis or enhance overall quality of life.

In this trial, participants will receive a pelvic health assessment and intervention, including pelvic physical therapy before treatment. Studies suggest that this therapy can reduce pelvic pain and make sex less painful. It may also help maintain pelvic floor muscle strength and prevent bladder control issues. Combining these methods before and during radiation treatment could improve pelvic health. ^{2 6 7 8 9}

Who Is on the Research Team?

Namita Agrawal, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dilator
• Pre-Rehabilitation

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Radiotherapy for gynecological cancers often leads to significant side effects in women, such as vaginal dryness, stenosis, and pain, affecting their sexual health, as analyzed in 19 studies involving 2,739 women.

While there is some evidence suggesting that pelvic floor muscle training (PFMT) may help manage sexual dysfunction after radiotherapy, the current studies are limited in quality and quantity, indicating a need for more rigorous research to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. Barcellini, A., Dominoni, M., Dal Mas, F., et al.[2022]

A consensus among 30 experts from 12 gynecological cancer centers established that radiation oncologists should provide information on sexual rehabilitation and vaginal dilator use before treatment, especially for sexually active patients under 70 years old.

The panel recommended starting vaginal dilation 4 weeks post-treatment, performing it 2 to 3 times a week for 1 to 3 minutes over a period of 9 to 12 months to prevent complications like vaginal adhesions and tightening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual rehabilitation after pelvic radiotherapy and vaginal dilator use: consensus using the Delphi method. Bakker, RM., ter Kuile, MM., Vermeer, WM., et al.[2018]

There is currently no rigorous research comparing the efficacy, cost, or patient preferences between plastic and silicone vaginal dilators for treating vaginal stenosis caused by radiation therapy, leaving patients and healthcare providers without clear guidance.

The lack of studies highlights a significant gap in knowledge, indicating a need for further research to understand the potential benefits of silicone dilators in improving quality of life for patients undergoing pelvic radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. Morgan, O., Lopez, MD., Martinez, AJC., et al.[2023]

There is currently no rigorous research comparing the efficacy, cost, or patient preferences between plastic and silicone vaginal dilators for treating vaginal stenosis caused by radiation therapy, leaving a significant knowledge gap.

This lack of data means that both healthcare providers and patients lack guidance in choosing between dilator types, highlighting the need for more studies to understand the potential benefits of silicone dilators in improving quality of life and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. Morgan, O., Lopez, MD., Martinez, AJC., et al.[2023]

Vaginal stenosis (VS) is a common complication of pelvic radiation therapy, influenced by factors such as radiation dose and the volume of the vagina exposed, which can lead to long-term changes affecting sexual function.

Vaginal dilator therapy (VDT) is recommended to prevent VS, but there is currently no standardized protocol or sufficient prospective data to determine the optimal duration or monitoring practices for VDT, highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Damast, S., Jeffery, DD., Son, CH., et al.[2021]

In a study of 28 women undergoing radiotherapy for cervical cancer, the combination of vaginal dilators and pelvic floor muscle exercises effectively prevented vaginal stenosis, with 90.9% of participants maintaining or increasing the size of their dilator after four months.

The intervention also supported sexual health, as 81.8% of the women remained sexually active, indicating a positive impact on their quality of life despite some emotional functioning limitations.

NCBI (Pubmed)

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. Araya-Castro, P., Sacomori, C., Diaz-Guerrero, P., et al.[2021]

A nurse-led sexual rehabilitation intervention for gynecologic cancer patients after pelvic radiation therapy showed promising feasibility, with 75% of participants regularly using vaginal dilators at 12 months.

Participants reported improved sexual functioning over time, indicating that the intervention may effectively support sexual recovery post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. Bakker, RM., Mens, JW., de Groot, HE., et al.[2022]

Women treated with pelvic radiotherapy often struggle to adopt vaginal dilator therapy due to feelings of being unprepared, stemming from unrealistic and insufficient information provided about the therapy.

Barriers to performing the therapy included physical discomfort and emotional fears, but women found success by developing supportive routines and strategies, highlighting the need for better communication and psychoeducation from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to and strategies for dealing with vaginal dilator therapy - Female pelvic cancer survivors' experiences: A qualitative study. Åkeflo, L., Elmerstig, E., Bergmark, K., et al.[2023]

Citations

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sciencedirect.com

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Women found that vaginal dilator therapy during prehabilitation enabled a sense of control and readiness for upcoming sexual and vaginal health ...

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pmc.ncbi.nlm.nih.gov

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Vaginal dilator therapy for women receiving pelvic radiotherapy

There is no reliable evidence to show that routine, regular vaginal dilation during radiotherapy treatment prevents stenosis or improves quality of life.

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withpower.com

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Pelvic Health Therapy for Pelvic Radiotherapy Patients

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After pelvic radiation therapy, pelvic dilators do increase vaginal volume and decrease vaginal stenosis but do not impact self-reported quality of life or ...

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In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer.

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Patients who receive pelvic radiation for gynecologic malignancies may experience a unique constellation of toxicity because of the anatomic locations.

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This study investigated the efficacy of a vaginal dilator (VD) for the treatment of radiation-induced vaginal stenosis (VS) and the effect ...

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Rehabilitation programs including pelvic floor muscle training (PFMT) and vaginal dilator exercises may help minimize post-radiation vaginal changes and ...