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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574323
• Other study ID #: 2020-01
• Status: Completed
• Phase: N/A
• Start date: March 19, 2020
• Est. completion date: July 16, 2020

Study information

• Verified date: December 2020
• Source: MVZ Leopoldina GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 16, 2020
• Est. primary completion date: June 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Metallic body parts
• Unable to comprehend the intervention

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Curative radiotherapy
Standard curative radiotherapy

Other:
• Paleolithic lifestyle intervention
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.

Locations

Country	Name	City	State
Germany	Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology	Schweinfurt	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
MVZ Leopoldina GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Klement RJ, Koebrunner PS, Krage K, Weigel MM, Sweeney RA. Short-term effects of a Paleolithic lifestyle intervention in breast cancer patients undergoing radiotherapy: a pilot and feasibility study. Med Oncol. 2020 Nov 28;38(1):1. doi: 10.1007/s12032-020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Longitudinal body composition changes	Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)	through study completion, an average of 5 weeks
Primary	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	Change in beta-hydroxybutyrate levels	Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels	through study completion, an average of 5 weeks