Breast CancerNCT04574323
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
A study testing Curative radiotherapy and Paleolithic lifestyle intervention in people with Breast Cancer and Body Weight Changes, run by MVZ Leopoldina GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Body Weight Changes
- What is being tested?
- Curative radiotherapy and Paleolithic lifestyle intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2020to 16 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index >18 kg/m^2
- Karnofsky performance index >60
Who cannot join
- Metallic body parts
- Unable to comprehend the intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site
Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
Schweinfurt, Bavaria, 97421
About this study
Official title: Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.
Read the 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.
- Conditions
- Breast Cancer, Body Weight Changes
- Being tested
- Curative radiotherapy, Paleolithic lifestyle intervention
- Keywords
- Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet
- Medical subject headings
- Breast Neoplasms, Body Weight Changes, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative radiotherapyRadiation
Standard curative radiotherapy
Paleolithic lifestyle interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Curative radiotherapy; Other: Paleolithic lifestyle intervention |
| Standard diet group | Other | This group is on a standard diet while receiving radiotherapy. Receives: Radiation: Curative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rate in the Paleolithic lifestyle intervention group
Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%
Measured: through study completion, an average of 5 weeks
Longitudinal body composition changes
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Measured: 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
Measured: through study completion, an average of 5 weeks
Secondary outcomes (1)
Change in beta-hydroxybutyrate levels
Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start19 Mar 2020
- Primary completion13 Jun 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- MVZ Leopoldina GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rainer Klement, MVZ Leopoldina GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574323
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Dec 2020
- First submitted
- 9 Sep 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33247817
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT04574323
- Acronym / sponsor ID
- 2020-01
- Conditions
- Breast Cancer, Body Weight Changes
- Keywords
- Bioimpedance analysis, Body composition, Nutrition, Oncology, Paleolithic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MVZ Leopoldina GmbHUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 13 Jun 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paleolithic lifestyle group | Experimental | Radiation: Curative radiotherapy, Other: Paleolithic lifestyle interventionThe 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. |
| Standard diet group | Other | Radiation: Curative radiotherapyThis group is on a standard diet while receiving radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index >18 kg/m^2
- Karnofsky performance index >60
Key exclusion criteria (2 listed)
- Metallic body parts
- Unable to comprehend the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative radiotherapyStandard curative radiotherapy | Radiation | Paleolithic lifestyle group, Standard diet group |
| Paleolithic lifestyle interventionThis 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 | Paleolithic lifestyle group |
Primary outcome
Dropout rate in the Paleolithic lifestyle intervention group
Time frame: 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
Time frame: through study completion, an average of 5 weeks
Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany)
Change in vitamin D levels
Time frame: through study completion, an average of 5 weeks
Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level
1 secondary outcome
Change in beta-hydroxybutyrate levels
Time frame: through study completion, an average of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Results publication: PubMed 33247817Klement 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curative radiotherapy and Paleolithic lifestyle intervention in people with Breast Cancer and Body Weight Changes, run by MVZ Leopoldina GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rate in the Paleolithic lifestyle intervention group (time frame: through study completion, an average of 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.