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)

Rehabilitation Clinical Trial

— ReCaP  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238596
• Other study ID #: ReCaP
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: September 6, 2025

Study information

• Verified date: January 2024
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: September 6, 2025
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Rehabilitation

Intervention

Procedure:
• rehabilitation
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.

Locations

Country	Name	City	State
Italy	SOC Oncologia Medica Provinciale	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence	Defined as percentage of patients who complete treatment schedule = 75%	12 weeks
Secondary	recruitment rate	percentage of patients who agree to adhere to the study	12 weeks, 24 weeks, 12 months
Secondary	retention rates	percentage of enrolled patients undergoing re-evaluation at these times	12 weeks, 24 weeks, 12 months
Secondary	safety	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;	baseline, 12 weeks, 24 weeks, 12 months
Secondary	hand grip strength (HGS)	dichotomized as <27 (low) and >=27Kg (normal)	baseline, 12 weeks, 24 weeks, 12 months
Secondary	physical activity (PA)	measured by International Physical Activity Questionnaire (IPAQ)	baseline, 12 weeks, 24 weeks, 12 months
Secondary	physical performance	measured by Short Physical Performance Battery (SPPB)	baseline, 12 weeks, 24 weeks, 12 months
Secondary	fatigue	measured by Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)	12 weeks, 24 weeks, 12 months