Metastatic Prostate Cancer (PCa) in ADT, Rehabilitation
Conditions
Keywords
Rehabilitation, feasibility, adverse events
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.
Interventions
PROCEDURErehabilitation
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.
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence | 12 weeks | Defined as percentage of patients who complete treatment schedule ≥ 75% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recruitment rate | 12 weeks, 24 weeks, 12 months | percentage of patients who agree to adhere to the study |
| retention rates | 12 weeks, 24 weeks, 12 months | percentage of enrolled patients undergoing re-evaluation at these times |
| Safety and Tolerability | baseline, 12 weeks, 24 weeks, 12 months | monitoring of accidental falls, traumatic and pathologic fractures occurred during the study course, and pain in the sites of bone metastasis (measured with NRS Scale); we will distinguish between AEs related to exercise program (pain or falls or fractures occurred during exercise sessions) from AEs not related to exercise; |
| hand grip strength (HGS) | baseline, 12 weeks, 24 weeks, 12 months | dichotomized as \<27 (low) and \>=27Kg (normal) |
| physical activity (PA) | baseline, 12 weeks, 24 weeks, 12 months | measured by International Physical Activity Questionnaire (IPAQ) |
| physical performance | baseline, 12 weeks, 24 weeks, 12 months | measured by Short Physical Performance Battery (SPPB) |
| fatigue | 12 weeks, 24 weeks, 12 months | measured by Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) |
Countries
Italy
Outcome results
None listed