Clinical trial NCT05861362: Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy
Official title: Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: MVZ Leopoldina GmbH
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Non-metastasized breast cancer
* Indication for curative radiotherapy

Exclusion Criteria:

* metallic body parts that would interfere with electric bioimpedance (BIA) measurements
* difficulties with understanding the aims of the study

Primary outcomes:
measure: Dropout rate in the FAST intervention group
timeFrame: Through study completion, an average of 5 weeks
measure: Longitudinal changes in body mass
timeFrame: Through study completion, an average of 5 weeks
measure: Longitudinal changes in fat-free mass
timeFrame: Through study completion, an average of 5 weeks
measure: Longitudinal changes in skeletal muscle mass
timeFrame: Through study completion, an average of 5 weeks
measure: Longitudinal changes in total body water
timeFrame: Through study completion, an average of 5 weeks
measure: Longitudinal changes in extracellular water
timeFrame: Through study completion, an average of 5 weeks
Secondary outcomes:
measure: Change between baseline and final (average 5 weeks) TyG index
timeFrame: Through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Department of Radiotherapy and Radiation Oncology
state: Bavaria
city: Schweinfurt
country: Germany
facility: Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
state: Bavaria
Study officials:
affiliation: Department of Radiation Oncology, Leopoldina Hospital Schweinfurt
name: Rainer J Klement, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: