ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03090217
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Information provided by (Responsible Party):
Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Pathological Constriction Behavioral: Pelvic Physiotherapy Behavioral: Standard care (SC) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial
Estimated Study Start Date : August 21, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : July 31, 2018

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 Name: PFMT

Behavioral: Standard care (SC)
1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Other Name: 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 Name: SC




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090217


Contacts
Contact: Fabrício E. Macagnan, MD +55 (51)99374-1286 ext cel fmacagnan@gmail.com
Contact: Patrícia V da Rosa, MD 5551982292289 ext cel patriciarosa@ufcspa.edu.br

Locations
Brazil
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Elizte Keitel, Dr    +55 (51) 3214.8571    cep@santacasa.tche.br   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
Study Chair: Taís M Cerentini, Bela. Federal University of Health Science of Porto Alegre

Publications:
ABHINAV, KR et al. Analysis of Late Radiation Proctitis Among Patients Treated for Cervical Cancer: A Comparative Study Between Linear Accelerator and Cobalt Teletherapy. Clinical Ovarian and Other Gynecologic Cancer, 6(1): 46-49, 2013.
BERNARDO, BC et al. Disfunção sexual em pacientes com câncer do colo uterino avançado submetidas à radioterapia exclusiva. Revista Brasileira de Ginecologia e Obstetrícia, 29(2): 85-90, 2007.
BO, K et al. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: II. Validity of vaginal pressure measurements of pelvic floor muscle strength and the necessity of supplementary methods for control of correct contraction. Neurourology and Urodynamics, 9(5): 479-487, 1990.
CANTEIRO, R. Avaliação do comprimento da cavidade uterina por meio da histerometria e ultrassom em mulheres nuligestas e com gestação prévia. 2009. 56 p. Dissertação de Mestrado para obtenção do grau Mestre em Tocoginecologia, área de Ciências Biomédicas.Campinas, SP. 2009.
CICONELLI, RM. Tradução para o português e validação do questionário genérico de avaliação de qualidade de vida Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Revista Brasileira de Reumatologia. 39(3), 1999.
FRIGATO, S; HOGA, LAK. Assistência à mulher com câncer de colo uterino: o papel da enfermagem. Rev Bras Cancerol, 49(4): 209-14, 2003.
HENTSCHEL, H et al. Validação do Female Sexual Function Index (FSFI) para uso em língua portuguesa. Rev HCPA, 27(1): 10-4, 2007.
Instituto Nacional de Câncer. Tipos de câncer. Disponível em: <http://www2.inca.gov.br/wps/wcm/connect/tiposdecancer/site/home/colo_utero/definicao>. Acesso em: 30.ago.2016.
Instituto Nacional de Câncer. Câncer do colo do útero. Disponível em: http://www.inca.gov.br/estimativa/2016/sintese-de-resultados-comentarios.asp. Acesso em 19.set.2016.
LATORRE, GFS et al. Escores de corte para o FSFI. Revista Inspirar Movimento & Saude, 7(1), 2015.
MENEZES, AMB; SANTOS, IS. Curso de epidemiologia básica para pneumologistas. Jornal Brasileiro de Pneumologia, 25(3): 163-166, 1999.
MORENO, A. Fisioterapia em Uroginecologia, Avaliação Fisioterapêutica, 1:101-112, 2004.
Organização Mundial de Saúde. Cadernos de atenção básica: controle dos cânceres do colo do útero e da mama. Brasilia: OMS, 2013. Ortiz OC, Coya NF, Ibanez G. Evaluación funcional del piso pelviano femenino (clasificación funcional). Soc Latinoam Uroginecol Cir Vaginal. 1996
ROSA, LM et al. Evaluation and classification of vaginal stenosis after brachytherapy. Texto & Contexto-Enfermagem, 25(2), 2016.
RESENDE, APM et al. Eletromiografia de superfície para avaliação dos músculos do assoalho pélvico feminino: revisão de literatura. Fisioterapia e Pesquisa, 2011
TAVARES, CMA; PRADO, ML. Pesquisando a prevenção do câncer ginecológico em Santa Catarina. Texto & contexto enferm, 15(4): 578-86, 2006.
WOLF, JK. Prevention and treatment of vaginal stenosis resulting from pelvic radiation therapy. Community oncology, 3(10): 665-671, 2006
VARTANIAN, JG et al. Questionários para a avaliação de qualidade de vida em pacientes com câncer de cabeça e pescoço validados no Brasil. Rev Bras Cir Cabeça Pescoço, 36(2): 108-15, 2007.

Responsible Party: Fabrício Edler Macagnan, Doctor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03090217     History of Changes
Other Study ID Numbers: PP-radiotherapy 2017
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: If shared, available after the end of the study through email taismcerentini@gmail.com

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre:
Radiotherapy
Brachytherapy
Physiotherapy
Vaginal dilators
Pelvic floor exercises
Vaginal Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical