Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy
NCT ID: NCT03090217
Last Updated: 2017-08-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
160 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-08-21
Study Completion Date
2018-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Gynecologic Cancer
Pathological Constriction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Pelvic Physiotherapy
Intervention Type
BEHAVIORAL
1\) daily pelvic floor muscle training (PFMT).
Standard care (SC)
Intervention Type
BEHAVIORAL
1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
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.
Group Type
ACTIVE_COMPARATOR
Standard care (SC)
Intervention Type
BEHAVIORAL
1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Interventions
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Pelvic Physiotherapy
1\) daily pelvic floor muscle training (PFMT).
Intervention Type
BEHAVIORAL
Standard care (SC)
1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Intervention Type
BEHAVIORAL
Other Intervention Names
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PFMT
SC
Eligibility Criteria
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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).
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Irmandade Santa Casa de Misericórdia de Porto Alegre
OTHER
Sponsor Role
collaborator
Federal University of Health Science of Porto Alegre
OTHER
Sponsor Role
lead
Responsible Party
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Fabrício Edler Macagnan
Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Taís M Cerentini, Bela.
Role: STUDY_CHAIR
Federal University of Health Science of Porto Alegre
Locations
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Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Cerentini TM, Schlottgen J, Viana da Rosa P, La Rosa VL, Vitale SG, Giampaolino P, Valenti G, Cianci S, Macagnan FE. Clinical and Psychological Outcomes of the Use of Vaginal Dilators After Gynaecological Brachytherapy: a Randomized Clinical Trial. Adv Ther. 2019 Aug;36(8):1936-1949. doi: 10.1007/s12325-019-01006-4. Epub 2019 Jun 17.
Reference Type
DERIVED
Other Identifiers
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PP-radiotherapy 2017
Identifier Type: -
Identifier Source: org_study_id
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Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer
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COMPLETED
Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga
NCT06411041
ENROLLING_BY_INVITATION
NA
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
NCT04269837
COMPLETED
NA
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
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COMPLETED
PHASE2
Head & Neck Cancer Survivorship: Physical and Functional Status
NCT00751816
COMPLETED
A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
NCT04072406
TERMINATED
NA
Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer
NCT06312917
COMPLETED
NA
Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors
NCT02465541
COMPLETED
NA
Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
NCT03722030
COMPLETED
NA
Prehabilitation in Gynaecological Cancer Patients
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RECRUITING
PHASE3
PFMT Educational Intervention for Patients With Advancer Breast Cancer
NCT04953377
UNKNOWN
NA
Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
NCT02444195
COMPLETED
NA
Mind-body Online Therapy in Gynecological Oncology
NCT05313724
UNKNOWN
NA
Effectiveness of a Modern Educational Intervention in Breast Cancer Patients
NCT03351075
COMPLETED
NA
Yoga for Solid Tumor
NCT03728205
WITHDRAWN
NA
Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
NCT06331403
COMPLETED
NA