Clinical trial NCT06238596: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Prostate Cancer (PCa) in ADT
Rehabilitation
Keywords: Rehabilitation
feasibility
adverse events
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: recruitment rate
timeFrame: 12 weeks, 24 weeks, 12 months
measure: retention rates
timeFrame: 12 weeks, 24 weeks, 12 months
measure: safety
timeFrame: baseline, 12 weeks, 24 weeks, 12 months
measure: hand grip strength (HGS)
timeFrame: baseline, 12 weeks, 24 weeks, 12 months
measure: physical activity (PA)
timeFrame: baseline, 12 weeks, 24 weeks, 12 months
measure: physical performance
timeFrame: baseline, 12 weeks, 24 weeks, 12 months
measure: fatigue
timeFrame: 12 weeks, 24 weeks, 12 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: SOC Oncologia Medica Provinciale
Study officials:
References: