Prostate Cancer
Conditions
Brief summary
The purpose of the study is to measure the muscle strength of the quadriceps 6 months from the start of the intervention, either the maximum load resistance that can be lifted in a single repetition under standardized conditions with the thigh press.
Detailed description
This is a prospective, longitudinal, open, comparative (two arms), randomized, monocentric study, focusing on a therapeutic strategy (muscle strengthening program with or without NeuroMuscular ElectroStimulation). Patients will be cared for according to a nutritional and sports support program offered routinely in the investigating center, which corresponds to the recommendations for the care of patients with prostate cancer under Androgen Deprivation Therapy.
Interventions
OTHERactivity sessions
77 activity sessions ; muscle strengthening, testing or unloading
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, longitudinal, open-label, comparative (two arms), randomized study
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient treated with pharmacological androgen deprivation therapy for prostate cancer for more than 26 weeks; * Performance index (WHO): 0 or 1; * Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study; * Patient benefiting from a social security scheme;
Exclusion criteria
* Weight ≥ 130 kg; * Vegetarian food; * Other associated neoplasia; * Patient having undergone a bilateral orchiectomy; * Painful bone metastases, or at risk of fracture; * Anemia (hemoglobin \< 10 g/dL); * Thrombocytopenia (platelets \< 50 G/L); * Renal impairment (creatinine clearance \< 60 mL/min, or albuminuria \> 30); * Patient planning to travel more than 4 weeks continuously in the next 52 weeks; * Absolute contraindication to physical training (e.g. musculoskeletal, cardiovascular or neurological disorders), according to the doctor specializing in the associated medical condition; * Contraindication to the use of the neuromuscular electrostimulation device or the impedance meter, in particular infectious disease in the acute phase, fungal infection, dermatitis, unbalanced arrhythmia, epilepsy, wearing an active implantable device (pacemaker, heart artificial, prosthesis incorporating an electromagnetic system), open wound; * Sports activity already supervised by a third party or at an equal or higher level than the bodybuilding/muscle strengthening work recommended in the study; * Protected adult patient (under guardianship or curatorship, or under a regime of deprivation of liberty); * Patient participating in another research, or in a period of exclusion from another research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps muscle strength | 6 months | Muscular strength of the quadriceps at 6 months from the start of the intervention, i.e. the maximum resistance / load that can be lifted in a single repetition, under standardized conditions. The main analysis is the comparison of quadriceps muscle strength (Maximum Resistance raised in 1 repetition) at 6 months between the groups with neuromuscular electrical stimulation and without neuromuscular electrical stimulation. |
Countries
France
Contacts
Primary ContactCélia LLORET LINARES, MD
Outcome results
None listed