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

MVZ Leopoldina GmbH

Status: Completed

Conditions: Breast Cancer; Body Weight Changes

Treatments: Other: Paleolithic lifestyle intervention; Radiation: Curative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04574323

2020-01

Details and patient eligibility

About

The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Paleolithic lifestyle group

Experimental 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.

Treatment:

Other: Paleolithic lifestyle intervention

Radiation: Curative radiotherapy

Standard diet group

Other group

Description:

This group is on a standard diet while receiving radiotherapy.

Treatment:

Radiation: Curative radiotherapy