Using neuromuscular stimulation to enhance muscle strength in prostate cancer patients

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

This study is testing if adding neuromuscular stimulation to a muscle strengthening program can help prostate cancer patients on hormone therapy build more muscle strength.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 90 Years
• Sex: Male
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Annemasse)
• Trial ID: NCT05745844 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of neuromuscular electrostimulation combined with a physical activity program on muscle strength in patients undergoing androgen deprivation therapy for prostate cancer. It is a prospective, longitudinal, open, comparative study that randomly assigns participants to receive either the muscle strengthening program with or without the electrostimulation intervention. The primary outcome is the measurement of quadriceps muscle strength after six months. Participants will also receive nutritional and sports support as part of their routine care.

Who should consider this trial

Good fit: Ideal candidates are prostate cancer patients on androgen deprivation therapy for over 26 weeks with a performance index of 0 or 1.

Not a fit: Patients with severe comorbidities, significant weight issues, or contraindications to physical training may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve muscle strength and overall physical function in prostate cancer patients undergoing treatment.

How similar studies have performed: While similar approaches have been explored, this specific combination of neuromuscular stimulation and physical activity in prostate cancer patients is relatively novel.

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.

Where this trial is running

Annemasse

• Hôpital privé Pays de Savoie — Annemasse, France (Recruiting)

Study contacts

• Study coordinator: Célia LLORET LINARES, MD

Conditions Prostate Cancer