Clinical trial NCT06694519: Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer
Official title: Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Genitourinary Syndrome
Radiofrequency
Physical Exercise
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Cardenal Herrera University
name: CAPENERGY MEDICAL, SL
First posted: 2024-11-19
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Breast cancer has a high impact, affecting 2.3 million women worldwide in 2022. In Spain, there were 40,203 new cases in 2023. In addition to the economic and social costs, patients suffer genitourinary dysfunctions due to cancer treatments. Genitourinary Menopausal Syndrome (GUS) affects 50% of menopausal women, with a higher prevalence in women with breast cancer.

This study aims to compare the effectiveness of radiofrequency (RF) and pelvic floor muscle exercise (PFMT) in the treatment of pelvic dysfunction associated with GUS in breast cancer patients. A randomised, double-blind clinical trial will be conducted in collaboration with the Association of Women Affected by Breast Cancer of Elche and Region) and the CEU Cardenal Herrera University. Women diagnosed with breast cancer and pelvic dysfunction will participate, divided into three groups: one will receive PFMT, one will receive RF and one will receive PFMT+RF therapy.

Both techniques are expected to improve the quality of life of patients, where RF could offer additional benefits due to its proven effectiveness in the treatment of vaginal dryness and dyspareunia. The expected results will contribute to more effective and less invasive treatment protocols. The project presented has the potential to positively impact the health and well-being of women with breast cancer, reducing the symptoms associated with the disease and its treatment, and improving their quality of life.


Eligibility criteria: Inclusion Criteria:

* women of legal age with a clinical history of breast cancer, who agree to participate in the study and who present pelvic dysfunction assessed by the Pelvic Floor Distress Inventory (PFDI20) ≥ 100
* women survivors of stage 1 and 2 breast cancer
* A medical discharge was granted more than one year ago
* A diagnosis of another type of cancer has not been made.

Exclusion Criteria:

* Having performed PMFT or received RF in the last 12 months
* Use of vaginal oestrogens in the last 6 months
* Systemic hormone therapy in the last 6 months
* Laser therapy in the last 6 months
* Absence of pelvic floor contraction according to the Modified Oxford Scale
* Use of pacemaker
* Use of heart pacemaker, decompensated heart or metabolic diseases, cognitive deficits, peripheral or central neurological disorders, previous surgeries in the pelvic region, skin pathologies or wounds in the treatment area or presence of an active urinary tract and/or vaginal infection.

Primary outcomes:
measure: PFDI-20 questionnaire (300 points)
timeFrame: Pre-intervention / a year post-intervention
Secondary outcomes:
measure: Age (years)
timeFrame: Pre-intervention
measure: Sex (female or male)
timeFrame: Pre-intervention
measure: Body mass index (Kg /m2)
timeFrame: Pre-intervention
measure: Pelvic floor muscle strength assessment (oxford scale 0-5 points)
timeFrame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
measure: neuromuscular stimulation device and PHENIX LIBERTY manometry (mmHg)
timeFrame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
measure: pH (0-14)
timeFrame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Cardenal Herrera - Ceu
state: Spain / Valencia
Study officials:
affiliation: CARDENAL HERRERA - CEU; CEU UNIVERSITIES
name: MERCEDES BLANQUET-ROCHERA, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: CARDENAL HERRERA - CEU; CEU UNIVERSITIES
name: CRISTINA ORTS-RUIZ, PhD
role: STUDY_DIRECTOR
affiliation: CARDENAL HERRERA - CEU; CEU UNIVERSITIES
name: JESÚS SÁNCHEZ-MAS, PhD
role: STUDY_DIRECTOR
References: