Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.

Detailed Description
-----------------
Tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. The aim of this work is evaluated the effects of the pelvic physiotherapy (PP) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. The PP will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.

Official Title
-----------------
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial

Conditions
-----------------
Gynecologic Cancer, Pathological Constriction

Intervention / Treatment
-----------------
* Behavioral: Pelvic Physiotherapy
* Behavioral: Standard care (SC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 years old; No vaginal stenosis at first evaluation; Women free of previous intracavitary radiation; Women diagnosed with gynecological cancer who are undergoing brachytherapy treatment during the period of research at the Santa Rita Hospital of the Santa Casa de Misericórdia in Porto Alegre; Women who agree to participate in the research through the Informed Consent Form (TCLE). Exclusion Criteria: Women who do not sign the ICF; Women not being treated for gynecological cancer; Women who have a 30% lack of physical therapy sessions (4 sessions); Women who present complications that prevent the accomplishment of the protocol of pelvic physiotherapy or that do not perform all the treatment with brachytherapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic physiotherapy (PP)<br>Pelvic Physiotherapy include daily pelvic floor muscle training (PFMT). PFMT starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment. | Behavioral: Pelvic Physiotherapy<br>* 1) daily pelvic floor muscle training (PFMT).<br>* Other names: PFMT;Behavioral: Standard care (SC)<br>* 1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.<br>* Other names: SC;|
| Active Comparator: Stander Care (SC)<br>The stander care (SC) includes a guideline for gynecological cancer patients under radiotherapy/brachytherapy: 1) daily vaginal dilator therapy (10 to 15 minutes); and 2) usual care management. This SC starts at first session of the brachytherapy and will be conduced during the twelve weeks treatment. | Behavioral: Standard care (SC)<br>* 1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.<br>* Other names: SC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Stenosis | Vaginal stenosis will be evaluated before the first brachytherapy and twelve months after. Considered according to the study of Kirchheiner et al., (2016) that used the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Vaginal stenosis will also be considered as the narrowing of the vaginal canal that makes it impossible to introduce the number 1 acrylic gynecological speculum through the vaginal introitus. | With completion of the study, predicted 15 months after the start of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The quality of live will be evaluated before the first brachytherapy and twelve months after through the application of the Quality of Life questionnaire European Organization for Research and Treatment of Cancer - EORTC QLQ-C30. | With completion of the study, predicted 15 months after the start of the study. | 
| Sexuality | The sexuality will be evaluated before the first brachytherapy and twelve months after through the application of the questionnaire The Female Sexual Function Index (FSFI). | With completion of the study, predicted 15 months after the start of the study. | 
| Muscle activity and contractile function of the pelvic floor | Measurement of pelvic floor activity will be evaluated before the first brachytherapy and twelve months after through surface electromyography (EMG), which is able to record the extracellular bioelectric activity generated by muscle fibers, through the electromyographic biofeedback Miotool 400 from Miotec. | With completion of the study, predicted 15 months after the start of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis