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

May 12, 2023 updated by: MVZ Leopoldina GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Schweinfurt, Bavaria, Germany, 97421
        • Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
      • Schweinfurt, Bavaria, Germany, 97421
        • Department of Radiotherapy and Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAST
5:2 intermittent fasting group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate in the FAST intervention group
Time Frame: Through study completion, an average of 5 weeks
Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%
Through study completion, an average of 5 weeks
Longitudinal changes in body mass
Time Frame: Through study completion, an average of 5 weeks
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
Longitudinal changes in fat-free mass
Time Frame: Through study completion, an average of 5 weeks
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
Longitudinal changes in skeletal muscle mass
Time Frame: Through study completion, an average of 5 weeks
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
Longitudinal changes in total body water
Time Frame: Through study completion, an average of 5 weeks
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
Longitudinal changes in extracellular water
Time Frame: Through study completion, an average of 5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change between baseline and final (average 5 weeks) TyG index
Time Frame: Through study completion, an average of 5 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MVZ Leopoldina GmbH

Investigators

  • Principal Investigator: Rainer J Klement, Ph.D., Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

November 17, 2022

Study Completion (Actual)

November 17, 2022

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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