Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study

Conditions
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Breast Cancer, Body Weight Changes

Intervention / Treatment
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* Radiation: Curative radiotherapy
* Other: Paleolithic lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index >18 kg/m^2 Karnofsky performance index >60 Exclusion Criteria: Metallic body parts Unable to comprehend the intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paleolithic lifestyle group<br>The Paleolithic lifestyle (PL) intervention during radiotherapy 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. Patients were supposed to start the PL intervention at least two days prior to the first irradiation and to protocol their food consumption on two days during the first week on the diet. They were also asked about their compliance to the PL intervention at each weekly measurement appointment. | Radiation: Curative radiotherapy<br>* Standard curative radiotherapy<br>Other: Paleolithic lifestyle intervention<br>* 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.<br>|
| Other: Standard diet group<br>This group is on a standard diet while receiving radiotherapy. | Radiation: Curative radiotherapy<br>* Standard curative radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rate in the Paleolithic lifestyle intervention group | Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30% | through study completion, an average of 5 weeks | 
| Longitudinal body composition changes | Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany) | 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 | through study completion, an average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in beta-hydroxybutyrate levels | Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels | through study completion, an average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet