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

Sponsor

MVZ Leopoldina GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT04574323

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Body Weight Changes	Radiation: Curative radiotherapy Other: Paleolithic lifestyle intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 19, 2020

Actual Primary Completion Date :

Jun 13, 2020

Actual Study Completion Date :

Jul 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paleolithic lifestyle group 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 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.
Other: Standard diet group This group is on a standard diet while receiving radiotherapy.	Radiation: Curative radiotherapy Standard curative radiotherapy

Arm

Intervention/Treatment

Experimental: Paleolithic lifestyle group

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

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.

Other: Standard diet group

This group is on a standard diet while receiving radiotherapy.

Radiation: Curative radiotherapy

Standard curative radiotherapy

Outcome Measures

Primary Outcome Measures

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%
Longitudinal body composition changes [through study completion, an average of 5 weeks]
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Metallic body parts
Unable to comprehend the intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology	Schweinfurt	Bavaria	Germany	97421

Sponsors and Collaborators

MVZ Leopoldina GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Rainer Klement, Principle investigator, MVZ Leopoldina GmbH

ClinicalTrials.gov Identifier:

NCT04574323

Other Study ID Numbers:

2020-01

First Posted:

Oct 5, 2020

Last Update Posted:

Dec 4, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Rainer Klement, Principle investigator, MVZ Leopoldina GmbH

Bioimpedance analysis

Additional relevant MeSH terms:

Breast Neoplasms

Body Weight

Body Weight Changes

Study Results

No Results Posted as of Dec 4, 2020