Breast CancerSTATICBREASTNCT04515888
Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer
An observational study of Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PFDI-20 / PFIQ-7 questionnaires
- How many people
- 246 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 6 Jul 2021
- Phase
- Observational
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy
Who may be able to join
- Women with Age ≥ 50 years
- Menopaused
- Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
- Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
- Patient who agreed, after receiving information, to participate to the study.
Who cannot join
- Metastatic breast cancer
- Patient with a history of pelvic static surgery
- Patient with a history of pelvic irradiation
- Patient unable or unwilling to complete the questionnaires
- Patient with a history of urinary incontinence treatment
- Patient not affiliated to the French social security system
Show all 10Show fewer
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation,
- Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
- Pregnant and / or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients
Read the detailed description
Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years.
Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.[5-9] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age.
These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse.
Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.
- Conditions
- Breast Cancer
- Being tested
- PFDI-20 / PFIQ-7 questionnaires
- Keywords
- localized breast cancer, pelvic static disorders, hormontherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFDI-20 / PFIQ-7 questionnairesOther
PFDI-20 / PFIQ-7 questionnaires (one shot)
| Study group | Role | What they receive |
|---|---|---|
| target population | The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. Receives: Other: PFDI-20 / PFIQ-7 questionnaires | |
| control population | The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy. Receives: Other: PFDI-20 / PFIQ-7 questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)
Measured: Day 1
Secondary outcomes (6)
Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy -
Measured: Day 1
Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - and patient hormontherapy +
Measured: Day 1
Evaluate the impact of pelvic static disorders on quality of life
Estimation of quality of life according to the PFIQ-7 (Pelvic Floor Impact Questionnaire) in the 2 populations. the total score of the PFIQ-7 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact))
Measured: Day 1
Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups
Estimation of pelvic symptoms scores according to the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire in the 2 populations. the total score of the PFDI-20 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact))
Measured: Day 1
Evaluate the correlation between hormone therapy and pelvic static disorders
Estimate the Rational rate between pelvic static disorders and hormone therapy with adjustment on known parameters : age, obesity, type of birth (vaginal or caesarean)
Measured: Day 1
Research the risk factors for pelvic static disorders
number of risk factors based on data collected
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start18 Sep 2020
- Primary completion12 Feb 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure DELMOND, MD, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515888
- Sponsor's protocol ID
- PROICM 2020-01 OST
- Acronym
- STATICBREAST
- Status last verified
- Nov 2021
- First submitted
- 7 Aug 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Reseau Francim; Reseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul-Aug;106(7-8):617-634. doi: 10.1016/j.bulcan.2018.11.016. Epub 2019 Mar 2. French.
PubMed 30833045Jones SE, Cantrell J, Vukelja S, Pippen J, O'Shaughnessy J, Blum JL, Brooks R, Hartung NL, Negron AG, Richards DA, Rivera R, Holmes FA, Chittoor S, Whittaker TL, Bordelon JH, Ketchel SJ, Davis JC, Ilegbodu D, Kochis J, Asmar L. Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy. J Clin Oncol. 2007 Oct 20;25(30):4765-71. doi: 10.1200/JCO.2007.10.8274.
PubMed 17947724Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5.
PubMed 17390926Chin SN, Trinkaus M, Simmons C, Flynn C, Dranitsaris G, Bolivar R, Clemons M. Prevalence and severity of urogenital symptoms in postmenopausal women receiving endocrine therapy for breast cancer. Clin Breast Cancer. 2009 May;9(2):108-17. doi: 10.3816/CBC.2009.n.020.
PubMed 19433392Sousa MS, Peate M, Jarvis S, Hickey M, Friedlander M. A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy. Ther Adv Med Oncol. 2017 Apr;9(4):269-285. doi: 10.1177/1758834016687260. Epub 2017 Jan 31.
PubMed 28491147Robinson PJ, Bell RJ, Christakis MK, Ivezic SR, Davis SR. Aromatase Inhibitors Are Associated With Low Sexual Desire Causing Distress and Fecal Incontinence in Women: An Observational Study. J Sex Med. 2017 Dec;14(12):1566-1574. doi: 10.1016/j.jsxm.2017.09.018. Epub 2017 Oct 21.
PubMed 29066307Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
PubMed 24463674Islam RM, Oldroyd J, Rana J, Romero L, Karim MN. Prevalence of symptomatic pelvic floor disorders in community-dwelling women in low and middle-income countries: a systematic review and meta-analysis. Int Urogynecol J. 2019 Dec;30(12):2001-2011. doi: 10.1007/s00192-019-03992-z. Epub 2019 Jun 4.
PubMed 31165221Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
PubMed 31851453Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018 Apr;29(4):459-476. doi: 10.1007/s00192-017-3467-4. Epub 2017 Sep 19.
PubMed 28929201Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol. 2010 Nov;203(5):514.e1-7. doi: 10.1016/j.ajog.2010.08.004. Epub 2010 Sep 24.
PubMed 20869691Neron M, Bastide S, Tayrac R, Masia F, Ferrer C, Labaki M, Boileau L, Letouzey V, Huberlant S. Impact of gynecologic cancer on pelvic floor disorder symptoms and quality of life: an observational study. Sci Rep. 2019 Feb 19;9(1):2250. doi: 10.1038/s41598-019-38759-5.
PubMed 30783163Wiegersma M, Panman CM, Berger MY, De Vet HC, Kollen BJ, Dekker JH. Minimal important change in the pelvic floor distress inventory-20 among women opting for conservative prolapse treatment. Am J Obstet Gynecol. 2017 Apr;216(4):397.e1-397.e7. doi: 10.1016/j.ajog.2016.10.010. Epub 2016 Oct 15.
PubMed 27751796Fallowfield LJ, Bliss JM, Porter LS, Price MH, Snowdon CF, Jones SE, Coombes RC, Hall E. Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol. 2006 Feb 20;24(6):910-7. doi: 10.1200/JCO.2005.03.3654.
PubMed 16484701
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
- ClinicalTrials.gov ID
- NCT04515888
- Acronym / sponsor ID
- STATICBREAST / PROICM 2020-01 OST
- Conditions
- Breast Cancer
- Keywords
- localized breast cancer, pelvic static disorders, hormontherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 17 Aug 2020 (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.
In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients
Detailed description
Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years.
Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.[5-9] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age.
These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse.
Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| target population | – | Other: PFDI-20 / PFIQ-7 questionnairesThe target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. |
| control population | – | Other: PFDI-20 / PFIQ-7 questionnairesThe control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy
Key inclusion criteria (5 listed)
- Women with Age ≥ 50 years
- Menopaused
- Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
- Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
- Patient who agreed, after receiving information, to participate to the study.
Key exclusion criteria (10 listed)
- Metastatic breast cancer
- Patient with a history of pelvic static surgery
- Patient with a history of pelvic irradiation
- Patient unable or unwilling to complete the questionnaires
- Patient with a history of urinary incontinence treatment
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 |
|---|---|---|
| PFDI-20 / PFIQ-7 questionnairesPFDI-20 / PFIQ-7 questionnaires (one shot) | Other | control population, target population |
Primary outcome
Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
Time frame: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)
6 secondary outcomes
Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)
Time frame: Day 1
Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +
Time frame: Day 1
Evaluate the impact of pelvic static disorders on quality of life
Time frame: Day 1
Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups
Time frame: Day 1
Evaluate the correlation between hormone therapy and pelvic static disorders
Time frame: Day 1
Research the risk factors for pelvic static disorders
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Results publication: PubMed 30833045Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Reseau Francim; Reseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul-Aug;106(7-8):617-634. doi: 10.1016/j.bulcan.2018.11.016. Epub 2019 Mar 2. French.
- Results publication: PubMed 17947724Jones SE, Cantrell J, Vukelja S, Pippen J, O'Shaughnessy J, Blum JL, Brooks R, Hartung NL, Negron AG, Richards DA, Rivera R, Holmes FA, Chittoor S, Whittaker TL, Bordelon JH, Ketchel SJ, Davis JC, Ilegbodu D, Kochis J, Asmar L. Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy. J Clin Oncol. 2007 Oct 20;25(30):4765-71. doi: 10.1200/JCO.2007.10.8274.
- Results publication: PubMed 17390926Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5.
- Results publication: PubMed 19433392Chin SN, Trinkaus M, Simmons C, Flynn C, Dranitsaris G, Bolivar R, Clemons M. Prevalence and severity of urogenital symptoms in postmenopausal women receiving endocrine therapy for breast cancer. Clin Breast Cancer. 2009 May;9(2):108-17. doi: 10.3816/CBC.2009.n.020.
- Results publication: PubMed 28491147Sousa MS, Peate M, Jarvis S, Hickey M, Friedlander M. A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy. Ther Adv Med Oncol. 2017 Apr;9(4):269-285. doi: 10.1177/1758834016687260. Epub 2017 Jan 31.
- Results publication: PubMed 29066307Robinson PJ, Bell RJ, Christakis MK, Ivezic SR, Davis SR. Aromatase Inhibitors Are Associated With Low Sexual Desire Causing Distress and Fecal Incontinence in Women: An Observational Study. J Sex Med. 2017 Dec;14(12):1566-1574. doi: 10.1016/j.jsxm.2017.09.018. Epub 2017 Oct 21.
- Results publication: PubMed 24463674Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
- Results publication: PubMed 31165221Islam RM, Oldroyd J, Rana J, Romero L, Karim MN. Prevalence of symptomatic pelvic floor disorders in community-dwelling women in low and middle-income countries: a systematic review and meta-analysis. Int Urogynecol J. 2019 Dec;30(12):2001-2011. doi: 10.1007/s00192-019-03992-z. Epub 2019 Jun 4.
- Results publication: PubMed 31851453Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
- Results publication: PubMed 28929201Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018 Apr;29(4):459-476. doi: 10.1007/s00192-017-3467-4. Epub 2017 Sep 19.
- Results publication: PubMed 20869691Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol. 2010 Nov;203(5):514.e1-7. doi: 10.1016/j.ajog.2010.08.004. Epub 2010 Sep 24.
- Results publication: PubMed 30783163Neron M, Bastide S, Tayrac R, Masia F, Ferrer C, Labaki M, Boileau L, Letouzey V, Huberlant S. Impact of gynecologic cancer on pelvic floor disorder symptoms and quality of life: an observational study. Sci Rep. 2019 Feb 19;9(1):2250. doi: 10.1038/s41598-019-38759-5.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Laure DELMOND, MD study chair
ICM Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 10 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: finished, as of the sponsor's last update on 4 Nov 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +). (time frame: Day 1). 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 NCT04515888, which also lists 14 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 4 Nov 2021.