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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25682
Enrollment
45
Registered
2020-10-07
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Breast Cancer

Interventions

1) dietary energy restriction (-30% from habitual intake), 2) daily exercise (30 min cycling at 70% HRmax, 30 min full body resistance-type exercise, 30 min walking).

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Female 2) BMI 20-35.0 kg/m2 3) Diagnosed with breast cancer, with treatment requiring a lumpectomy or mastectomy

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

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.

Secondary

MeasureTime frame
Differences between intervention groups in concentrations of circulating anabolic hormones (e.g., estrogen, insulin, growth hormone), growth factors (e.g., IGF-1, IGFBP-1, IGFBP-3), and (pro- and anti-inflammatory) cytokines (e.g., C-reactive protein, IL-1, IL-6, TNF-alpha, IL-10).

Contacts

Public ContactAndrew Holwerda

Maastricht University

andy.holwerda@maastrichtuniversity.nl043-3881381

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)