The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients

Cancer of Prostate Clinical Trial

— DIRECT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406803
• Other study ID #: f/2023/047
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

Intervention

Behavioral:
• Dietary energy restriction
Patients enrolled in the dietary energy restriction group will reach an energy deficit of 40% only through reduced dietary intake.
• Daily exercise
Patients in the daily exercise group will reach an energy deficit of 40% through reduced dietary intake and increased physical activity (exercise).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Jessa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour protein synthesis rates	Measured using the deuterated water (2H2O) method	7 days pre-operatively
Primary	Muscle protein synthesis rates	Measured using the deuterated water (2H2O) method	7 days pre-operatively