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ID
Source
Brief title
Health condition
Breast Cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Subjects will be randomly assigned to undergo 7 days of either caloric restriction, an exercise program, or standard treatment. The caloric restriction group will undergo a 30% reduction in daily energy intake (~500-600 kcal). The exercise group will increase daily energy expenditure by 30% (~500-600 kcal) by performing 1 h of combined resistance- and endurance-type exercise and 30 min of walking. Patients following standard treatment will act as the control group. All subjects will ingest small amounts of deuterium oxide (2H2O) throughout the 7-day period. The 7-day period will end with the tumor resection surgery, during which a tumor tissue sample, skeletal muscle sample, and plasma sample will be collected. Protein will be isolated from the tissue samples and analyzed for the increase in 2H-alanine enrichment to determine average tumor and muscle tissue protein synthesis rates over the 7-day assessment period (in %/d).
Study objective
It is hypothesized that both caloric restriction and exercise lower tumor tissue protein synthesis rates but that exercise, as opposed to caloric restriction, will prevent a concomitant decline in muscle tissue protein synthesis rates.
Study design
0 days, 7 days
Intervention
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).
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8958 |
| Other | Maastricht University Medical Center+ METC : METC 20-040 |