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

Not Applicable

Completed

• Conditions: Body Weight Changes; Breast Cancer

• Registration Number: NCT04574323
• Lead Sponsor: MVZ Leopoldina GmbH

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.

Study Timeline

• Study Start: 2020-03-19
• Primary Completion: 2020-06-13
• Study Completion: 2020-07-16
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

• Metallic body parts
• Unable to comprehend the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Longitudinal body composition changes	through study completion, an average of 5 weeks	Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
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%
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 Outcome Measures

Name	Time	Method
Change in beta-hydroxybutyrate levels	through study completion, an average of 5 weeks	Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels

Trial Locations

Locations (1)

Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology; 🇩🇪 Schweinfurt, Bavaria, Germany