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Trial Title:
The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients
NCT ID:
NCT06406803
Condition:
Cancer of Prostate
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Dietary energy restriction
Description:
Patients enrolled in the dietary energy restriction group will reach an energy deficit of
40% only through reduced dietary intake.
Arm group label:
Dietary energy restriction
Intervention type:
Behavioral
Intervention name:
Daily exercise
Description:
Patients in the daily exercise group will reach an energy deficit of 40% through reduced
dietary intake and increased physical activity (exercise).
Arm group label:
Daily exercise
Summary:
Background: Prostate cancer is the second most common cancer and the fifth leading cause
of death in men worldwide. Tumour growth is attributed to disproportionately greater
protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is
modulated by several factors, including energy availability, blood flow, and hormone
concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as
important adjunct therapeutic approaches to slow cancer development and enhance treatment
efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces
an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle
mass often declines during cancer treatment and negatively impacts treatment success
rates and recovery. One drawback to dietary energy restriction is that it may accelerate
declines in skeletal muscle mass and strength in cancer patients. Exercise also induces
an energy deficit by increasing energy expenditure. In addition, exercise alters blood
flow and releases circulating molecules, which appear to lower tumour protein synthesis
rates. Exercise increases muscle protein synthesis rates, which would provide further
benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their
promising therapeutic properties, the clinical efficacy of dietary energy restriction and
exercise has not been directly determined in vivo in cancer patients.
Hypothesis and Objectives: The objective of this study is to compare the impact of
dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and
prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer
patients.
It is hypothesized that 1) dietary energy restriction will lower both prostate tumour and
muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate
tumour protein synthesis rates but increase muscle protein synthesis rates in prostate
cancer patients.
Setting and Methods: Forty-five prostate cancer patients scheduled to undergo radical
prostatectomy will be randomly assigned to one of three groups. The first group will
undergo 7 days of dietary energy restriction (40% less food intake). The second group
will perform 7 days of daily exercise and mild dietary energy restriction resulting in a
total energy deficit of 40%. The third group will follow their regular diet and physical
activity (control group). The research team will provide all aspects of the intervention
(standardized meals, personalized exercise supervision). Patients will ingest
deuterium-labelled water (2H2O) throughout the intervention period. After 7 days,
patients will undergo a radical prostatectomy, during which tumour tissue, skeletal
muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the
tissue samples will be measured to assess prostate tumour and skeletal muscle tissue
protein synthesis rates.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with prostate cancer (Stages I-III)
- Scheduled to undergo a prostatectomy
- BMI between 18.5-35 kg/m2
Exclusion Criteria:
- Receiving pre-operative chemo, hormonal, radio therapy
- Physically unable to perform the exercise program
- Performing >300 min of moderate-vigorous physical activity per week (e.g., running,
road cycling, swimming).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Jessa Hospital
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406803
