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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| control population | The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFDI-20 / PFIQ-7 questionnaires | Other | PFDI-20 / PFIQ-7 questionnaires (one shot) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 +) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 - | Day 1 |
| Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy + |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Laure DELMOND, MD | ICM Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icm Val D'Aurelle | Montpellier | Herault | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833045 | Result | 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. | |
| 17947724 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - and patient hormontherapy + |
| 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)) | 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)) | 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) | Day 1 |
| Research the risk factors for pelvic static disorders | number of risk factors based on data collected | Day 1 |
| Jones 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. |
| 17390926 | Result | Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5. |
| 19433392 | Result | Chin 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. |
| 28491147 | Result | Sousa 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. |
| 29066307 | Result | Robinson 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. |
| 24463674 | Result | Wu 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. |
| 31165221 | Result | Islam 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. |
| 31851453 | Result | Weintraub 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. |
| 28929201 | Result | Ramaseshan 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. |
| 20869691 | Result | Rutledge 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. |
| 30783163 | Result | Neron 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. |
| 27751796 | Result | Wiegersma 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. |
| 16484701 | Result | Fallowfield 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. |
| D017437 |
| Skin and Connective Tissue Diseases |