The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Standard curative radiotherapy
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.
Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
Schweinfurt, Bavaria, Germany
Dropout rate in the Paleolithic lifestyle intervention group
Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%
Time frame: through study completion, an average of 5 weeks
Longitudinal body composition changes
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Time frame: through study completion, an average of 5 weeks
Change in vitamin D levels
Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level
Time frame: through study completion, an average of 5 weeks
Change in beta-hydroxybutyrate levels
Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels
Time frame: through study completion, an average of 5 weeks
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