Clinical trial NCT03090217: Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy
Official title: Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Pathological Constriction
Keywords: Radiotherapy
Brachytherapy
Physiotherapy
Vaginal dilators
Pelvic floor exercises
Vaginal Stenosis
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
First posted: 2017-03-24
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Vaginal Stenosis
timeFrame: With completion of the study, predicted 15 months after the start of the study.
Secondary outcomes:
measure: Quality of life
timeFrame: With completion of the study, predicted 15 months after the start of the study.
measure: Sexuality
timeFrame: With completion of the study, predicted 15 months after the start of the study.
measure: Muscle activity and contractile function of the pelvic floor
timeFrame: With completion of the study, predicted 15 months after the start of the study.
Other outcomes:
measure: The vaginal area
timeFrame: With completion of the study, predicted 15 months after the start of the study.
Locations:
city: Porto Alegre
country: Brazil
facility: Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Taís M Cerentini, Bela.
role: STUDY_CHAIR
References:
citation: 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.
citation: Auchincloss CC, McLean L. The reliability of surface EMG recorded from the pelvic floor muscles. J Neurosci Methods. 2009 Aug 30;182(1):85-96. doi: 10.1016/j.jneumeth.2009.05.027. Epub 2009 Jun 17.
citation: Bahng AY, Dagan A, Bruner DW, Lin LL. Determination of prognostic factors for vaginal mucosal toxicity associated with intravaginal high-dose rate brachytherapy in patients with endometrial cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):667-73. doi: 10.1016/j.ijrobp.2010.10.071. Epub 2011 Feb 6.
citation: Bakker RM, Vermeer WM, Creutzberg CL, Mens JW, Nout RA, Ter Kuile MM. Qualitative accounts of patients' determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015 Mar;12(3):764-73. doi: 10.1111/jsm.12776. Epub 2014 Nov 25.
citation: Bernards AT, Berghmans BC, Slieker-Ten Hove MC, Staal JB, de Bie RA, Hendriks EJ. Dutch guidelines for physiotherapy in patients with stress urinary incontinence: an update. Int Urogynecol J. 2014 Feb;25(2):171-9. doi: 10.1007/s00192-013-2219-3. Epub 2013 Oct 1.
citation: 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.
citation: Bi X, Zhao J, Zhao L, Liu Z, Zhang J, Sun D, Song L, Xia Y. Pelvic floor muscle exercise for chronic low back pain. J Int Med Res. 2013 Feb;41(1):146-52. doi: 10.1177/0300060513475383. Epub 2013 Jan 23.
citation: Brand AH, Bull CA, Cakir B. Vaginal stenosis in patients treated with radiotherapy for carcinoma of the cervix. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):288-93. doi: 10.1111/j.1525-1438.2006.00348.x.
citation: Brand AH, Do V, Stenlake A. Can an educational intervention improve compliance with vaginal dilator use in patients treated with radiation for a gynecological malignancy? Int J Gynecol Cancer. 2012 Jun;22(5):897-904. doi: 10.1097/IGC.0b013e31824d7243.
citation: 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.
citation: Bruner DW, Lanciano R, Keegan M, Corn B, Martin E, Hanks GE. Vaginal stenosis and sexual function following intracavitary radiation for the treatment of cervical and endometrial carcinoma. Int J Radiat Oncol Biol Phys. 1993 Nov 15;27(4):825-30. doi: 10.1016/0360-3016(93)90455-5.
citation: Bruner DW, Nolte SA, Shahin MS, Huang HQ, Sobel E, Gallup D, Cella D; Gynecologic Oncology Group. Measurement of vaginal length: Reliability of the vaginal sound--a Gynecologic Oncology Group study. Int J Gynecol Cancer. 2006 Sep-Oct;16(5):1749-55. doi: 10.1111/j.1525-1438.2006.00711.x.
citation: 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.
citation: Carpenter JS, Reed SD, Guthrie KA, Larson JC, Newton KM, Lau RJ, Learman LA, Shifren JL. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015 Mar;3(1):7-13. doi: 10.1002/sm2.53.
citation: Carter J, Goldfrank D, Schover LR. Simple strategies for vaginal health promotion in cancer survivors. J Sex Med. 2011 Feb;8(2):549-59. doi: 10.1111/j.1743-6109.2010.01988.x. Epub 2010 Aug 16.
citation: 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.
citation: Nascimento-Correia G, Santos-Pereira V, Tahara N, Driusso P. [Effects of pelvic floor muscle training on quality of life of a group of women with urinary incontinence: randomized controlled trial]. Actas Urol Esp. 2012 Apr;36(4):216-21. doi: 10.1016/j.acuro.2011.07.007. Epub 2011 Sep 28. Spanish.
citation: Cullen K, Fergus K, Dasgupta T, Fitch M, Doyle C, Adams L. From "sex toy" to intrusive imposition: a qualitative examination of women's experiences with vaginal dilator use following treatment for gynecological cancer. J Sex Med. 2012 Apr;9(4):1162-73. doi: 10.1111/j.1743-6109.2011.02639.x. Epub 2012 Feb 3.
citation: Cullen K, Fergus K, DasGupta T, Kong I, Fitch M, Doyle C, Adams L. Toward clinical care guidelines for supporting rehabilitative vaginal dilator use with women recovering from cervical cancer. Support Care Cancer. 2013 Jul;21(7):1911-7. doi: 10.1007/s00520-013-1726-6. Epub 2013 Feb 17.
citation: Decruze SB, Guthrie D, Magnani R. Prevention of vaginal stenosis in patients following vaginal brachytherapy. Clin Oncol (R Coll Radiol). 1999;11(1):46-8. doi: 10.1053/clon.1999.9008.
citation: Denton AS, Maher EJ. Interventions for the physical aspects of sexual dysfunction in women following pelvic radiotherapy. Cochrane Database Syst Rev. 2003;2003(1):CD003750. doi: 10.1002/14651858.CD003750.
citation: Faubion SS, MacLaughlin KL, Long ME, Pruthi S, Casey PM. Surveillance and Care of the Gynecologic Cancer Survivor. J Womens Health (Larchmt). 2015 Nov;24(11):899-906. doi: 10.1089/jwh.2014.5127. Epub 2015 Jul 24.
citation: Flay LD, Matthews JH. The effects of radiotherapy and surgery on the sexual function of women treated for cervical cancer. Int J Radiat Oncol Biol Phys. 1995 Jan 15;31(2):399-404. doi: 10.1016/0360-3016(94)E0139-B.
citation: Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
citation: Franceschini J, Jardim JR, Fernandes AL, Jamnik S, Santoro IL. Reproducibility of the Brazilian Portuguese version of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire used in conjunction with its lung cancer-specific module. J Bras Pneumol. 2010 Sep-Oct;36(5):595-602. doi: 10.1590/s1806-37132010000500011. English, Portuguese.
citation: FRIGATO, S; HOGA, LAK. Assistência à mulher com câncer de colo uterino: o papel da enfermagem. Rev Bras Cancerol, 49(4): 209-14, 2003.
citation: Grape HH, Dedering A, Jonasson AF. Retest reliability of surface electromyography on the pelvic floor muscles. Neurourol Urodyn. 2009;28(5):395-9. doi: 10.1002/nau.20648.
citation: Grion RC, Baccaro LF, Vaz AF, Costa-Paiva L, Conde DM, Pinto-Neto AM. Sexual function and quality of life in women with cervical cancer before radiotherapy: a pilot study. Arch Gynecol Obstet. 2016 Apr;293(4):879-86. doi: 10.1007/s00404-015-3874-z. Epub 2015 Aug 29.
citation: Hata M, Koike I, Miyagi E, Numazaki R, Asai-Sato M, Kasuya T, Kaizu H, Matsui T, Hirahara F, Inoue T. Radiation therapy for pelvic lymph node metastasis from uterine cervical cancer. Gynecol Oncol. 2013 Oct;131(1):99-102. doi: 10.1016/j.ygyno.2013.07.085. Epub 2013 Jul 19.
citation: HENTSCHEL, H et al. Validação do Female Sexual Function Index (FSFI) para uso em língua portuguesa. Rev HCPA, 27(1): 10-4, 2007.
citation: Huang Z, Zheng Y, Wen W, Wu C, Bao P, Wang C, Zhong W, Gao YT, Jin F, Xiang YB, Shu XO, Beeghly-Fadiel A. Incidence and mortality of gynaecological cancers: Secular trends in urban Shanghai, China over 40 years. Eur J Cancer. 2016 Aug;63:1-10. doi: 10.1016/j.ejca.2016.04.016. Epub 2016 May 26.
citation: 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.
citation: 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.
citation: KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.
citation: Kirchheiner K, Nout RA, Lindegaard JC, Haie-Meder C, Mahantshetty U, Segedin B, Jurgenliemk-Schulz IM, Hoskin PJ, Rai B, Dorr W, Kirisits C, Bentzen SM, Potter R, Tanderup K; EMBRACE Collaborative Group. Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study. Radiother Oncol. 2016 Jan;118(1):160-6. doi: 10.1016/j.radonc.2015.12.025. Epub 2016 Jan 9.
citation: Knorst MR, Resende TL, Santos TG, Goldim JR. The effect of outpatient physical therapy intervention on pelvic floor muscles in women with urinary incontinence. Braz J Phys Ther. 2013 Sep-Oct;17(5):442-9. doi: 10.1590/S1413-35552012005000117. Epub 2013 Oct 21. English, Portuguese.
citation: Lancaster L. Preventing vaginal stenosis after brachytherapy for gynaecological cancer: an overview of Australian practices. Eur J Oncol Nurs. 2004 Mar;8(1):30-9. doi: 10.1016/S1462-3889(03)00059-0.
citation: LATORRE, GFS et al. Escores de corte para o FSFI. Revista Inspirar Movimento & Saude, 7(1), 2015.
citation: Law E, Kelvin JF, Thom B, Riedel E, Tom A, Carter J, Alektiar KM, Goodman KA. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy. Radiother Oncol. 2015 Jul;116(1):149-55. doi: 10.1016/j.radonc.2015.06.018. Epub 2015 Jul 8.
citation: Mahmud A, Brydon B, Tonita J, Hanna TP, Schmidt M, Tai P. A population-based study of cervix cancer: incidence, management and outcome in the Canadian province of Saskatchewan. Clin Oncol (R Coll Radiol). 2011 Dec;23(10):691-5. doi: 10.1016/j.clon.2011.05.002. Epub 2011 Jun 8.
citation: MENEZES, AMB; SANTOS, IS. Curso de epidemiologia básica para pneumologistas. Jornal Brasileiro de Pneumologia, 25(3): 163-166, 1999.
citation: Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007291. doi: 10.1002/14651858.CD007291.pub2.
citation: Mohamed S, Lindegaard JC, de Leeuw AA, Jurgenliemk-Schulz I, Kirchheiner K, Kirisits C, Potter R, Tanderup K. Vaginal dose de-escalation in image guided adaptive brachytherapy for locally advanced cervical cancer. Radiother Oncol. 2016 Sep;120(3):480-485. doi: 10.1016/j.radonc.2016.05.020. Epub 2016 Jun 3.
citation: MORENO, A. Fisioterapia em Uroginecologia, Avaliação Fisioterapêutica, 1:101-112, 2004.
citation: Nunns D, Williamson K, Swaney L, Davy M. The morbidity of surgery and adjuvant radiotherapy in the management of endometrial carcinoma. Int J Gynecol Cancer. 2000 May;10(3):233-238. doi: 10.1046/j.1525-1438.2000.010003233.x.
citation: Occhino JA, Trabuco EC, Heisler CA, Klingele CJ, Gebhart JB. Changes in vaginal anatomy and sexual function after vaginal surgery. Int Urogynecol J. 2011 Jul;22(7):799-804. doi: 10.1007/s00192-011-1386-3. Epub 2011 Mar 17.
citation: Olson B, Gribble B, Dias J, Curryer C, Vo K, Kowal P, Byles J. Cervical cancer screening programs and guidelines in low- and middle-income countries. Int J Gynaecol Obstet. 2016 Sep;134(3):239-46. doi: 10.1016/j.ijgo.2016.03.011. Epub 2016 May 26.
citation: 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
citation: Park HS, Ratner ES, Lucarelli L, Polizzi S, Higgins SA, Damast S. Predictors of vaginal stenosis after intravaginal high-dose-rate brachytherapy for endometrial carcinoma. Brachytherapy. 2015 Jul-Aug;14(4):464-70. doi: 10.1016/j.brachy.2015.03.001. Epub 2015 Apr 14.
citation: Phillips K, Hersch J, Turner R, Jansen J, McCaffery K. The influence of the 'cancer effect' on young women's responses to overdiagnosis in cervical screening. Patient Educ Couns. 2016 Oct;99(10):1568-75. doi: 10.1016/j.pec.2016.04.002. Epub 2016 Apr 16.
citation: Polat M, Kahramanoglu I, Senol T, Senturk B, Ozkaya E, Karateke A. Comparison of the Effect of Laparoscopic and Abdominal Hysterectomy on Lower Urinary Tract Function, Vaginal Length, and Dyspareunia: A Randomized Clinical Trial. J Laparoendosc Adv Surg Tech A. 2016 Feb;26(2):116-21. doi: 10.1089/lap.2015.0437. Epub 2015 Dec 15.
citation: Rakhra SS, Weaver C, Donnelly ED, Helenowski I, Prescott AE, Strauss JB. The effect of pelvic radiotherapy on vaginal brachytherapy cylinder diameter: Implications for optimal treatment order. Brachytherapy. 2016 Sep-Oct;15(5):549-53. doi: 10.1016/j.brachy.2016.04.391. Epub 2016 Jun 14.
citation: ROSA, LM et al. Evaluation and classification of vaginal stenosis after brachytherapy. Texto & Contexto-Enfermagem, 25(2), 2016.
citation: Rosenbaum TY. Pelvic floor involvement in male and female sexual dysfunction and the role of pelvic floor rehabilitation in treatment: a literature review. J Sex Med. 2007 Jan;4(1):4-13. doi: 10.1111/j.1743-6109.2006.00393.x.
citation: RESENDE, APM et al. Eletromiografia de superfície para avaliação dos músculos do assoalho pélvico feminino: revisão de literatura. Fisioterapia e Pesquisa, 2011
citation: Santa Mina D, Au D, Alibhai SM, Jamnicky L, Faghani N, Hilton WJ, Stefanyk LE, Ritvo P, Jones J, Elterman D, Fleshner NE, Finelli A, Singal RK, Trachtenberg J, Matthew AG. A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol. BMC Urol. 2015 Sep 16;15:94. doi: 10.1186/s12894-015-0088-4.
citation: Soares EM, Riul da Silva S. [Profile of patients with gynecological cancer under chemotherapy]. Rev Bras Enferm. 2010 Jul-Aug;63(4):517-22. doi: 10.1590/s0034-71672010000400003. Portuguese.
citation: TAVARES, CMA; PRADO, ML. Pesquisando a prevenção do câncer ginecológico em Santa Catarina. Texto & contexto enferm, 15(4): 578-86, 2006.
citation: Thomas GM. Improved treatment for cervical cancer--concurrent chemotherapy and radiotherapy. N Engl J Med. 1999 Apr 15;340(15):1198-200. doi: 10.1056/NEJM199904153401509. No abstract available.
citation: WOLF, JK. Prevention and treatment of vaginal stenosis resulting from pelvic radiation therapy. Community oncology, 3(10): 665-671, 2006
citation: Wright JJ, O'Connor KM. Female sexual dysfunction. Med Clin North Am. 2015 May;99(3):607-28. doi: 10.1016/j.mcna.2015.01.011. Epub 2015 Mar 6.
citation: Yoshida K, Yamazaki H, Nakamura S, Masui K, Kotsuma T, Akiyama H, Tanaka E, Yoshikawa N, Uesugi Y, Shimbo T, Narumi Y, Yoshioka Y. Role of vaginal pallor reaction in predicting late vaginal stenosis after high-dose-rate brachytherapy in treatment-naive patients with cervical cancer. J Gynecol Oncol. 2015 Jul;26(3):179-84. doi: 10.3802/jgo.2015.26.3.179. Epub 2015 Apr 29.
citation: Schover LR, Fife M, Gershenson DM. Sexual dysfunction and treatment for early stage cervical cancer. Cancer. 1989 Jan 1;63(1):204-12. doi: 10.1002/1097-0142(19890101)63:13.0.co;2-u.
citation: Schvartzman R, Bertotto A, Schvartzman L, Wender MC. Pelvic floor muscle activity, quality of life, and sexual function in peri- and recently postmenopausal women with and without dyspareunia: a cross-sectional study. J Sex Marital Ther. 2014;40(5):367-78. doi: 10.1080/0092623X.2013.864363. Epub 2014 Jan 9.
citation: 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.
citation: Zomkowski K, Toryi AM, Sacomori C, Dias M, Sperandio FF. Sexual function and quality of life in gynecological cancer pre- and post-short-term brachytherapy: a prospective study. Arch Gynecol Obstet. 2016 Oct;294(4):833-40. doi: 10.1007/s00404-016-4099-5. Epub 2016 Apr 27.
citation: 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.