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Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy (PPPVSSR)

Primary Purpose

Gynecologic Cancer, Pathological Constriction

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pelvic Physiotherapy
Standard care (SC)
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gynecologic Cancer focused on measuring Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pelvic physiotherapy (PP)

Stander Care (SC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 12, 2017
Last Updated
August 21, 2017
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03090217
Brief Title
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy
Acronym
PPPVSSR
Official Title
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2017 (Anticipated)
Primary Completion Date
May 31, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Pathological Constriction
Keywords
Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic physiotherapy (PP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Stander Care (SC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Physiotherapy
Other Intervention Name(s)
PFMT
Intervention Description
1) daily pelvic floor muscle training (PFMT).
Intervention Type
Behavioral
Intervention Name(s)
Standard care (SC)
Other Intervention Name(s)
SC
Intervention Description
1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Primary Outcome Measure Information:
Title
Vaginal Stenosis
Description
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.
Time Frame
With completion of the study, predicted 15 months after the start of the study.
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
With completion of the study, predicted 15 months after the start of the study.
Title
Sexuality
Description
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).
Time Frame
With completion of the study, predicted 15 months after the start of the study.
Title
Muscle activity and contractile function of the pelvic floor
Description
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.
Time Frame
With completion of the study, predicted 15 months after the start of the study.
Other Pre-specified Outcome Measures:
Title
The vaginal area
Description
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.
Time Frame
With completion of the study, predicted 15 months after the start of the study.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrício E. Macagnan, MD
Phone
+55 (51)99374-1286
Ext
cel
Email
fmacagnan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patrícia V da Rosa, MD
Phone
5551982292289
Ext
cel
Email
patriciarosa@ufcspa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taís M Cerentini, Bela.
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizte Keitel, Dr
Phone
+55 (51) 3214.8571
Email
cep@santacasa.tche.br

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If shared, available after the end of the study through email taismcerentini@gmail.com
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Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy

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