Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy

Breast Cancer Clinical Trial

Official title:

Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861362
• Other study ID #: 2022-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 17, 2022

Study information

• Verified date: May 2023
• Source: MVZ Leopoldina GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Curative radiotherapy
Curative radiotherapy as indicated by the patient's disease and prescribed by the treating radiation oncologist

Behavioral:
• 5:2 intermittent fasting
Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.

Locations

Country	Name	City	State
Germany	Department of Radiotherapy and Radiation Oncology	Schweinfurt	Bavaria
Germany	Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology	Schweinfurt	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
MVZ Leopoldina GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropout rate in the FAST intervention group	Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%	Through study completion, an average of 5 weeks
Primary	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).	Through study completion, an average of 5 weeks
Primary	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).	Through study completion, an average of 5 weeks
Primary	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).	Through study completion, an average of 5 weeks
Primary	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).	Through study completion, an average of 5 weeks
Primary	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).	Through study completion, an average of 5 weeks
Secondary	Change between baseline and final (average 5 weeks) TyG index	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)	Through study completion, an average of 5 weeks