Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

Prostate Cancer Clinical Trial

— HORMES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745844
• Other study ID #: 2022-A00904-39
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Célia LLORET LINARES, MD
• Phone: 632494057
• Email: celialloret[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• activity sessions
77 activity sessions ; muscle strengthening, testing or unloading

Locations

Country	Name	City	State
France	Hôpital privé Pays de Savoie	Annemasse

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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