Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-02
Brief Title:
The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
The Impact of Physical Activity Versus Dietary Energy Restriction on Prostate Tumour and Muscle Tissue Protein Synthesis in Vivo in Prostate Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIRECT
Brief 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 eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None