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Completed

NCT Number: NCT04574323

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

The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.

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Key information

Conditions

Breast Cancer Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index >18 kg/m^2
  • Karnofsky performance index >60

Exclusion criteria

  • Metallic body parts
  • Unable to comprehend the intervention

Treatment and study plan

Curative radiotherapy

Radiation

Standard curative radiotherapy

Paleolithic lifestyle intervention

Other

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.

Primary outcomes

  1. Dropout rate in the Paleolithic lifestyle intervention group

    Time frame: through study completion, an average of 5 weeks

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

  2. Longitudinal body composition changes

    Time frame: through study completion, an average of 5 weeks

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

  3. Change in vitamin D levels

    Time frame: through study completion, an average of 5 weeks

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

Secondary outcomes

  1. Change in beta-hydroxybutyrate levels

    Time frame: through study completion, an average of 5 weeks

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

Sponsors and collaborators

Lead sponsor

MVZ Leopoldina GmbH

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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