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The impact of caloric restriction versus exercise on tumor and muscle tissue protein synthesis rates in breast cancer patients

The impact of caloric restriction versus exercise on tumor and muscle tissue protein synthesis rates in breast cancer patients - CREX Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56422
Enrollment
45
Registered
2020-08-05
Start date
2021-05-17
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer muscle

Interventions

Caloric restriction: The caloric restriction group will be subjected to a 30% reduction in daily dietary energy intake (500-600 kcal per day) while maintaining the same relative macronutrient intake

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Female 2) BMI 18.5-35.0 kg/m2 3) Diagnosed with breast cancer, with treatment requiring a lumpectomy

Exclusion criteria

Exclusion criteria: 1) Patients receiving preoperative chemo- or radio-therapy 2) >5% weight loss in the previous 6 months 3) Fasting glucose >7 mmol/L 4) Musculoskeletal injuries (which may interfere with performing the exercise program) 5) Participation in structured resistance exercise program 6) A history of neuromuscular problems 7) Use of anti-coagulants 8) Use of protein and/or fish-oil supplements 9) Participation in a 2H2O study in the previous 6 months

Design outcomes

Secondary

MeasureTime frame
Healthy breast tissue protein synthesis rates over the 7-day intervention period. Plasma concentrations of estrogen, insulin, growth hormone, IGF-1, IGFBP-1, IGFBP-3, C-reactive protein, IL-1, IL-6, TNF-alpha, IL-10.

Primary

MeasureTime frame
1. Tumor tissue protein synthesis rates over the 7-day intervention period in breast cancer patients. 2. Muscle tissue protein synthesis rates over the 7-day intervention period in breast cancer patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)