Pelvic Health Therapy for Pelvic Radiotherapy Patients

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

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}

Research Team

Namita Agrawal, MD

Principal Investigator

Indiana University

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

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
• 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. [2022]

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

Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. [2021]

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]

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]

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]

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

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. [2023]

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

Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. [2023]

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

Sexual rehabilitation after pelvic radiotherapy and vaginal dilator use: consensus using the Delphi method. [2018]