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

NCT04574323 | Completed

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Body Weight Changes

Keywords

Bioimpedance analysis; Body composition; Nutrition; Oncology; Paleolithic diet

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in beta-hydroxybutyrate levels

  through study completion, an average of 5 weeks

Study Arms (2)

Paleolithic lifestyle group

EXPERIMENTAL

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; Other: Paleolithic lifestyle intervention

Standard diet group

OTHER

This group is on a standard diet while receiving radiotherapy.

Radiation: Curative radiotherapy

Interventions

Curative radiotherapy RADIATION

Standard curative radiotherapy

Paleolithic lifestyle group; Standard diet group

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.

Paleolithic lifestyle group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Metallic body parts
• Unable to comprehend the intervention

Sponsors & Collaborators

• MVZ Leopoldina GmbH: lead

Study Sites (1)

Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

Location

Related 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/s12032-020-01443-0.

  PMID: 33247817 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Body Weight Changes; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 5, 2020
• Study Start: March 19, 2020
• Primary Completion: June 13, 2020
• Study Completion: July 16, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data can be requested from now on.
• Access Criteria: A reasonable request to the study P.I. (Dr. Klement) suffices.

Locations

DE (1)