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

Management of Patients Under Anti-HORMonal Treatment for Prostate Cancer : Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: activity sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Célia LLORET LINARES, MD; Phone Number: +33 632494057; Email: celialloret@yahoo.fr

Study Locations

• France
  • Annemasse, France, 74100
    • Recruiting
    • Hôpital Privé Pays de Savoie
    • Contact: Célia LLORET-LINARES, MD; Phone Number: +33 632494057; Email: celialloret@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuroMuscular Electro Stimulation group; 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	Other: activity sessions; 77 activity sessions ; muscle strengthening, testing or unloading
Active Comparator: Control Group; The control group (without NeuroMuscular Electro Stimulation) corresponds to the standard care routinely offered to patients in the investigating centre.	Other: activity sessions; 77 activity sessions ; muscle strengthening, testing or unloading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps muscle strength	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.	6 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2022-A00904-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No