Clinical trial · Interventional
Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
NCT04574323CI-TRIAL-00048637completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight Changes | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curative radiotherapy | Radiation | — | UNRESOLVED |
| Paleolithic lifestyle intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paleolithic lifestyle group
- 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.
- interventionNames
- Radiation: Curative radiotherapy
- Other: Paleolithic lifestyle intervention
- type
- OTHER
- label
- Standard diet group
- description
- This group is on a standard diet while receiving radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Body mass index \>18 kg/m\^2 * Karnofsky performance index \>60 Exclusion Criteria: * Metallic body parts * Unable to comprehend the intervention
References
Publications (1)
- RESULTKlement 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