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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Curative radiotherapy
5:2 intermittent fasting
Sponsored by
MVZ Leopoldina GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiotherapy and Radiation Oncology
  • Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FAST

Arm Description

5:2 intermittent fasting group

Outcomes

Primary Outcome Measures

Dropout rate in the FAST intervention group
Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30%
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).
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).
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).
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).
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).

Secondary Outcome Measures

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)

Full Information

First Posted
May 2, 2023
Last Updated
May 12, 2023
Sponsor
MVZ Leopoldina GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05861362
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MVZ Leopoldina GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAST
Arm Type
Experimental
Arm Description
5:2 intermittent fasting group
Intervention Type
Radiation
Intervention Name(s)
Curative radiotherapy
Intervention Description
Curative radiotherapy as indicated by the patient's disease and prescribed by the treating radiation oncologist
Intervention Type
Behavioral
Intervention Name(s)
5:2 intermittent fasting
Intervention Description
Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.
Primary Outcome Measure Information:
Title
Dropout rate in the FAST intervention group
Description
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
Title
Longitudinal changes in body mass
Description
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
Title
Longitudinal changes in fat-free mass
Description
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
Title
Longitudinal changes in skeletal muscle mass
Description
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
Title
Longitudinal changes in total body water
Description
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
Title
Longitudinal changes in extracellular water
Description
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
Secondary Outcome Measure Information:
Title
Change between baseline and final (average 5 weeks) TyG index
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer J Klement, Ph.D.
Organizational Affiliation
Department of Radiation Oncology, Leopoldina Hospital Schweinfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiotherapy and Radiation Oncology
City
Schweinfurt
State/Province
Bavaria
ZIP/Postal Code
97421
Country
Germany
Facility Name
Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
City
Schweinfurt
State/Province
Bavaria
ZIP/Postal Code
97421
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available upon reasonable request

Learn more about this trial

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

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