Clinical trial NCT05745844: Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
Official title: Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-02-27
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, longitudinal, open-label, comparative (two arms), randomized study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quadriceps muscle strength
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Hôpital privé Pays de Savoie
Study officials:
References: