Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Body Weight Changes

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Dermatologic Agents

Vitamins

Herbal and Botanical

Vitamin D

Cholecalciferol

Sunscreening Agents

Vitamin D3

Calciferol

Coconut

Olive

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.

This group is on a standard diet while receiving radiotherapy.

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.

Paleolithic lifestyle intervention

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.

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

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

Will be made available upon reasonable request. Plan is also to publish all data of this and the KETOCOMP study (NCT02516501) together as soon as all analyses have been published.

Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%

Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)

Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level

Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy	NCT04574323	Breast Cancer Body Weight Cha...	Curative radiot... Paleolithic lif...	18 Years - 75 Years	MVZ Leopoldina GmbH

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