Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

Trial Title: Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

NCT ID: NCT06238596

Condition: Metastatic Prostate Cancer (PCa) in ADT
Rehabilitation

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Rehabilitation
feasibility
adverse events

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: rehabilitation
Description: The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.
Arm group label: rehabilitation + standard of care (SOC)

Summary: This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility. The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT. Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits. The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients. At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ). The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly. For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years. Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosis of prostatic adenocarcinoma; - Metastatic disease candidate to ADT treatment and ADT free; - ECOG PS 0-1. Exclusion Criteria: - Physical conditions that may limit adherence to the study (heart failure NYHA 3-4, pathologic fractures, previous disability limiting exercise, etc); - Psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.) - Other concomitant active malignancies

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: SOC Oncologia Medica Provinciale

Address:
City: Reggio Emilia
Zip: 42123
Country: Italy

Status: Recruiting

Contact:
Last name: Stefania Di Girolamo, MD

Phone: 0522296601
Email: stefania.digirolamo@ausl.re.it

Start date: September 6, 2023

Completion date: September 6, 2025

Lead sponsor:
Agency: Azienda Unità Sanitaria Locale Reggio Emilia
Agency class: Other

Source: Azienda Unità Sanitaria Locale Reggio Emilia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06238596