- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05850182
Lifestyle Intervention in Patients With Metastatic Prostate Cancer (ACTIDIET-PRO)
A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prostate cancer (PCa) is among the most frequent tumor types and is the second deadliest type of cancer in men.
PCa has a multifactorial aetiology; modifiable environmental factors, including diet and obesity, have been associated with prostate carcinogenesis. Furthermore, patients with PCa are treated with androgen deprivation therapy (ADT), which has negative effects on the cardiovascular system and body composition, particularly on the fat and muscle mass, bone health and psychological wellbeing.
Data in the current literature suggests that a lifestyle intervention e.g. with targeted and supervised exercise therapy or a dietary intervention with a prudent dietary patternmay positively influence the quality of life and the course of the disease of patients under ADT. However, conclusive data is missing.
The proposed pilot study aims at determining the feasibility and the effect of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with PCa under ADT.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luigi Tortola, PhD
- Phone Number: +41 91 811 96 68
- Email: luigi.tortola@eoc.ch
Study Contact Backup
- Name: Ursula Vogl, MD
- Phone Number: +41 91 811 84 63
- Email: ursula.vogl@eoc.ch
Study Locations
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-
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Bellinzona, Switzerland, 6500
- Oncology Institute of Southern Switzerland (IOSI)
-
Contact:
- Luigi Tortola, PhD
- Phone Number: +41 91 811 96 68
- Email: luigi.tortola@eoc.ch
-
Contact:
- Ursula Vogl, MD
- Phone Number: +41 91 811 84 63
- Email: ursula.vogl@eoc.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent according to ICH/GCP regulations before registration.
- Age ≥ 18 years
- Histology of adenocarcinoma of the prostate
- Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)
- Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation
- PSA doubling time > 8 weeks
- Continuation of ongoing systemic treatment is deemed feasible by treating physician
Exclusion Criteria:
- Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments
- Evidence of clinical progression or progression of disease on imaging
- Bone metastases excluding the safety of physical exercise
- Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures
- Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)
- Clinically significant chronic obstructive pulmonary disease
- Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm treated with lifestyle intervention
Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.
|
12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient initiation rate
Time Frame: 12 weeks
|
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
|
12 weeks
|
Patient retention rate
Time Frame: 12 weeks
|
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
|
12 weeks
|
Adherence to prescribed training program
Time Frame: 12 weeks
|
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
|
12 weeks
|
Adherence to prescribed dietary regimen
Time Frame: 12 weeks
|
Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of lifestyle intervention on PSA progression
Time Frame: 24 weeks
|
Percentage of PSA non-progressors (patients with <25% PSA rise compared to baseline) at weeks 8, 12 and 24
|
24 weeks
|
Effect of lifestyle intervention on PSA levels
Time Frame: 24 weeks
|
PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope [PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)]
|
24 weeks
|
Effect of lifestyle intervention on radiographic progression
Time Frame: 24 weeks
|
Percentage of patients being free of radiographic progression according to PCWG3 at weeks 12 and 24
|
24 weeks
|
Effect of lifestyle intervention on patient-reported quality of life
Time Frame: 24 weeks
|
Change in patient-reported quality of life from baseline using Functional Assessment of Cancer Therapy - Prostate (FACT-P) scoring from baseline to weeks 8, 12 and 24
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24 weeks
|
Effect of lifestyle intervention on patient-reported fatigue
Time Frame: 24 weeks
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Change in patient-reported fatigue from baseline using FACIT Fatigue scoring from baseline to weeks 8, 12 and 24
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24 weeks
|
Effect of lifestyle intervention on time to subsequent treatment
Time Frame: 24 months
|
Time to a subsequent line of treatment (in weeks)
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24 months
|
Effect of lifestyle intervention on plasma lipid signature
Time Frame: 8 weeks
|
Concentration of individual lipid types in the plasma of participating patients, change compared to baseline
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8 weeks
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Effect of lifestyle intervention on plasma immune signature
Time Frame: 8 weeks
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Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
|
8 weeks
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Effect of lifestyle intervention on microbiome composition
Time Frame: 8 weeks
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Differences in community diversity and/or abundance of specific bacterial taxa within the intestinal microbiome prior to or during the lifestyle intervention.
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8 weeks
|
Effect of lifestyle intervention on anthropometric variables
Time Frame: 24 weeks
|
Measurement of patient height and body weight and calculation of body-mass index (BMI) at baseline, during and after the lifesyle intervention.
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24 weeks
|
Effect of lifestyle intervention on lean body mass
Time Frame: 12 weeks
|
Measurement of the percentage of lean body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
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12 weeks
|
Effect of lifestyle intervention on fat body mass
Time Frame: 12 weeks
|
Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTIDIET-PRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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