Breast Cancer, Body Weight Changes
Conditions
Keywords
Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet
Brief summary
The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.
Detailed description
A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a Paleolithic lifestyle (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.
Interventions
RADIATIONCurative radiotherapy
Standard curative radiotherapy
OTHERPaleolithic lifestyle intervention
This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed.
Sponsors
MVZ Leopoldina GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index \>18 kg/m\^2 * Karnofsky performance index \>60
Exclusion criteria
* Metallic body parts * Unable to comprehend the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dropout rate in the Paleolithic lifestyle intervention group | through study completion, an average of 5 weeks | Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30% |
| Longitudinal body composition changes | through study completion, an average of 5 weeks | Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany) |
| Change in vitamin D levels | through study completion, an average of 5 weeks | Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in beta-hydroxybutyrate levels | through study completion, an average of 5 weeks | Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels |
Countries
Germany
Outcome results
None listed