Clinical trial NCT04515888: Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer
Official title: Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: localized breast cancer
pelvic static disorders
hormontherapy
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 246
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
timeFrame: Day 1
Secondary outcomes:
measure: Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)
timeFrame: Day 1
measure: Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +
timeFrame: Day 1
measure: Evaluate the impact of pelvic static disorders on quality of life
timeFrame: Day 1
measure: Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups
timeFrame: Day 1
measure: Evaluate the correlation between hormone therapy and pelvic static disorders
timeFrame: Day 1
measure: Research the risk factors for pelvic static disorders
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
Study officials:
affiliation: ICM Val d'Aurelle
name: Laure DELMOND, MD
role: STUDY_CHAIR
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