Gynecologic Cancer, Pathological Constriction
Conditions
Keywords
Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis
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.
Interventions
BEHAVIORALPelvic Physiotherapy
1\) daily pelvic floor muscle training (PFMT).
BEHAVIORALStandard care (SC)
1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Stenosis | With completion of the study, predicted 15 months after the start of the study. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | With completion of the study, predicted 15 months after the start of the study. | 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. |
| Sexuality | With completion of the study, predicted 15 months after the start of the study. | 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). |
| Muscle activity and contractile function of the pelvic floor | With completion of the study, predicted 15 months after the start of the study. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The vaginal area | With completion of the study, predicted 15 months after the start of the study. | The vaginal area will be evaluated before the first brachytherapy and twelve months after through A-SÒS-labeled vaginal dilators in eight different sizes in square centimeters and the vaginal length will be measured with a hysterometer, introduced into the vaginal canal until it reaches the cervix (from the himenal ring to the Posterior fornice), the measurement will be in centimeters. |
Countries
Brazil
Contacts
Primary ContactFabrício E. Macagnan, MD
Backup ContactPatrícia V da Rosa, MD
Outcome results
None listed