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

August 21, 2017 updated by: Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fabrício E. Macagnan, MD
  • Phone Number: cel +55 (51)99374-1286
  • Email: fmacagnan@gmail.com

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic physiotherapy (PP)
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
1) daily pelvic floor muscle training (PFMT).
Other Names:
  • PFMT
Behavioral: Standard care (SC)
1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Other Names:
  • SC
Active Comparator: Stander Care (SC)
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)
1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Other Names:
  • SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Stenosis
Time Frame: 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.
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
Time Frame: 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.
With completion of the study, predicted 15 months after the start of the study.
Sexuality
Time Frame: 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).
With completion of the study, predicted 15 months after the start of the study.
Muscle activity and contractile function of the pelvic floor
Time Frame: 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.
With completion of the study, predicted 15 months after the start of the study.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The vaginal area
Time Frame: 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.
With completion of the study, predicted 15 months after the start of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Collaborators

Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Study Chair: Taís M Cerentini, Bela., Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 21, 2017

Primary Completion (Anticipated)

May 31, 2018

Study Completion (Anticipated)

July 31, 2018

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP-radiotherapy 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

If shared, available after the end of the study through email taismcerentini@gmail.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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