Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program (HORMES)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: activity sessions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05745844

2022-A00904-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

NeuroMuscular Electro Stimulation group

Experimental group

Description:

Patients in the NeuroMuscular Electro Stimulation group will also have neurostimulation sessions using a CE marked medical device, in its destination, according to its instructions for use, therefore without expected clinical risk

Treatment:

Other: activity sessions

Control Group

Active Comparator group

Description:

The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.

Treatment:

Other: activity sessions