Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer

Breast Cancer Clinical Trial

— STATICBREAST  

Official title:

Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515888
• Other study ID #: PROICM 2020-01 OST
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: July 6, 2021

Study information

• Verified date: November 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: July 6, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• PFDI-20 / PFIQ-7 questionnaires
PFDI-20 / PFIQ-7 questionnaires (one shot)

Locations

Country	Name	City	State
France	Icm Val D'Aurelle	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View Citation

Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Réseau Francim; Réseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul - Aug — View Citation

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 wome — View Citation

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: 10.1 — View Citation

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 sy — View Citation

Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5. Review. — View Citation

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- — View Citation

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. Review. — View Citation

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.2017.0 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 +	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Research the risk factors for pelvic static disorders	number of risk factors based on data collected	Day 1

External Links

•   ESMO Clinical Practice Guidelines