The intervention consists of the adoption of a 5:2 intermittent fasting diet during radiotherapy of breast cancer patients. The aim of the study was to assess the feasibility of this intervention and its impact on body composition and selected metabolic blood parameters.
The 5:2 intermittent fasting (FAST) intervention consisted of two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule. The minimum amount of time to count as a fasting day was 24 hours, but patients were advised to aim for a complete fasting day including the nights before and after that day. On a fasting day, only water and unsweetened tea or coffee was allowed. However, given that fat is the macronutrient interfering the least with the metabolic adaptions to fasting, while carbohydrates disturb the most \[26\], patients were allowed to consume small amounts of bone broth/meat broth, coconut oil, butter/ghee or heavy cream as an "emergency plan", i.e., in case that they felt they needed some energy-containing foods to complete an initiated fasting day. The primary study outcome was the feasibility of the FAST intervention and its effects on longitudinal body composition changes from baseline until the final week of radiotherapy (body mass, fat mass, fat-free mass, muscle mass, extracellular and total body water). Secondary endpoints were absolute changes in metabolic parameters, hormones, and overall quality of life scores in the FAST group. As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) was calculated according to TyG=ln(fasting triglycerides \[mg/dl\]×fasting glucose \[mg/dl\]/ 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Curative radiotherapy as indicated by the patient's disease and prescribed by the treating radiation oncologist
Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.
Department of Radiotherapy and Radiation Oncology
Schweinfurt, Bavaria, Germany
Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
Schweinfurt, Bavaria, Germany
Dropout rate in the FAST intervention group
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
Longitudinal changes in body mass
Body mass (in kg) is measured by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).
Time frame: Through study completion, an average of 5 weeks
Longitudinal changes in fat-free mass
Fat-free mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).
Time frame: Through study completion, an average of 5 weeks
Longitudinal changes in skeletal muscle mass
Skeletal muscle mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).
Time frame: Through study completion, an average of 5 weeks
Longitudinal changes in total body water
Total body water content (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).
Time frame: Through study completion, an average of 5 weeks
Longitudinal changes in extracellular water
Extracellular water (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).
Time frame: Through study completion, an average of 5 weeks
Change between baseline and final (average 5 weeks) TyG index
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As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) is calculated according to TyG=ln(fasting triglycerides \[mg/dl\]×fasting glucose \[mg/dl\]/ 2)
Time frame: Through study completion, an average of 5 weeks