Gynecologic CancerPPPVSSRNCT03090217
Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to the Radiotherapy
A study testing Pelvic Physiotherapy in people with Gynecologic Cancer and Pathological Constriction, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Pathological Constriction
- What is being tested?
- Pelvic Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Aug 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul
Elizte Keitel, Dr, +55 (51) 3214.8571, cep@santacasa.tche.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Cancer, Pathological Constriction
- Being tested
- Pelvic Physiotherapy, Standard care (SC)
- Keywords
- Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic PhysiotherapyBehavioural
Also called PFMT
- daily pelvic floor muscle training (PFMT).
Standard care (SC)Behavioural
Also called SC
- daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic physiotherapy (PP) | Experimental | 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. Receives: Behavioral: Pelvic Physiotherapy; Behavioral: Standard care (SC) |
| Stander Care (SC) | Active comparator | 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. Receives: Behavioral: Standard care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: With completion of the study, predicted 15 months after the start of the study.
Secondary outcomes (3)
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.
Measured: With completion of the study, predicted 15 months after the start of the study.
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).
Measured: With completion of the study, predicted 15 months after the start of the study.
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.
Measured: With completion of the study, predicted 15 months after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Aug 2017 (estimated)
- Primary completion31 May 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
- Investigators
- Taís M Cerentini, Bela., Study chair, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090217
- Sponsor's protocol ID
- PP-radiotherapy 2017
- Acronym
- PPPVSSR
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If shared, available after the end of the study through email taismcerentini@gmail.com
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.
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.
PubMed 19539646Bahng 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.
PubMed 21300451Bakker 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.
PubMed 25424559Bernards 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.
PubMed 24081496BERNARDO, 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.
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.
PubMed 23569140Brand 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.
PubMed 16445647Brand 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.
PubMed 22552831BO, 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.
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.
PubMed 8244811Bruner 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.
PubMed 17009966CANTEIRO, 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.
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.
PubMed 25844170Carter 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.
PubMed 20722792
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03090217
- Acronym / sponsor ID
- PPPVSSR / PP-radiotherapy 2017
- Conditions
- Gynecologic Cancer, Pathological Constriction
- Keywords
- Radiotherapy, Brachytherapy, Physiotherapy, Vaginal dilators, Pelvic floor exercises, Vaginal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 21 Aug 2017 (estimated)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic physiotherapy (PP) | Experimental | Behavioral: Pelvic Physiotherapy, Behavioral: Standard care (SC)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. |
| Stander Care (SC) | Active comparator | Behavioral: Standard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic PhysiotherapyAlso: PFMT1) daily pelvic floor muscle training (PFMT). | Behavioural | Pelvic physiotherapy (PP) |
| Standard care (SC)Also: SC1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management. | Behavioural | Pelvic physiotherapy (PP), Stander Care (SC) |
Primary outcome
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.
3 secondary outcomes
Quality of life
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- BackgroundABHINAV, 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.
- Background: PubMed 19539646Auchincloss 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.
- Background: PubMed 21300451Bahng 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.
- Background: PubMed 25424559Bakker 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.
- Background: PubMed 24081496Bernards 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.
- BackgroundBERNARDO, 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.
- Background: PubMed 23569140Bi 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.
- Background: PubMed 16445647Brand 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.
- Background: PubMed 22552831Brand 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.
- BackgroundBO, 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.
- Background: PubMed 8244811Bruner 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.
- Background: PubMed 17009966Bruner 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.
- Individual participant dataSharing planned: No. If shared, available after the end of the study through email taismcerentini@gmail.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taís M Cerentini, Bela. study chair
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Physiotherapy in people with Gynecologic Cancer and Pathological Constriction, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrício E. Macagnan, MD (+55 (51)99374-1286 ext. cel, fmacagnan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Stenosis (time frame: With completion of the study, predicted 15 months after the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090217, which also lists 67 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.