Back to resultsEffects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
Primary Purpose
Breast Cancer, Body Weight Changes
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Curative radiotherapy
Paleolithic lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet
Eligibility Criteria
Inclusion Criteria:
- Body mass index >18 kg/m^2
- Karnofsky performance index >60
Exclusion Criteria:
- Metallic body parts
- Unable to comprehend the intervention
Sites / Locations
- Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Paleolithic lifestyle group
Standard diet group
Arm Description
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.
This group is on a standard diet while receiving radiotherapy.
Outcomes
Primary Outcome Measures
Dropout rate in the Paleolithic lifestyle intervention group
Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%
Longitudinal body composition changes
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Change in vitamin D levels
Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level
Secondary Outcome Measures
Change in beta-hydroxybutyrate levels
Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels
Full Information
NCT ID
NCT04574323
First Posted
September 9, 2020
Last Updated
December 2, 2020
Sponsor
MVZ Leopoldina GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04574323
Brief Title
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
Official Title
Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
June 13, 2020 (Actual)
Study Completion Date
July 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MVZ Leopoldina GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Body Weight Changes
Keywords
Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paleolithic lifestyle group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard diet group
Arm Type
Other
Arm Description
This group is on a standard diet while receiving radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Curative radiotherapy
Intervention Description
Standard curative radiotherapy
Intervention Type
Other
Intervention Name(s)
Paleolithic lifestyle intervention
Intervention Description
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 Outcome Measure Information:
Title
Dropout rate in the Paleolithic lifestyle intervention group
Description
Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%
Time Frame
through study completion, an average of 5 weeks
Title
Longitudinal body composition changes
Description
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Time Frame
through study completion, an average of 5 weeks
Title
Change in vitamin D levels
Description
Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level
Time Frame
through study completion, an average of 5 weeks
Secondary Outcome Measure Information:
Title
Change in beta-hydroxybutyrate levels
Description
Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels
Time Frame
through study completion, an average of 5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index >18 kg/m^2
Karnofsky performance index >60
Exclusion Criteria:
Metallic body parts
Unable to comprehend the intervention
Facility Information:
Facility Name
Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
City
Schweinfurt
State/Province
Bavaria
ZIP/Postal Code
97421
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will be made available upon reasonable request. Plan is also to publish all data of this and the KETOCOMP study (NCT02516501) together as soon as all analyses have been published.
IPD Sharing Time Frame
The data can be requested from now on.
IPD Sharing Access Criteria
A reasonable request to the study P.I. (Dr. Klement) suffices.
Citations:
PubMed Identifier
33247817
Citation
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.
Results Reference
result
Learn more about this trial
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
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