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

NCT ID: NCT05861362

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-11-17

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

FAST

5:2 intermittent fasting group

Group Type: EXPERIMENTAL

Curative radiotherapy

Intervention Type: RADIATION

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

5:2 intermittent fasting

Intervention Type: BEHAVIORAL

Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.

Interventions

Curative radiotherapy

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

Intervention Type: RADIATION

5:2 intermittent fasting

Two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MVZ Leopoldina GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer J Klement, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

Locations

Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, Germany

Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, Germany

Countries

Germany

Other Identifiers

2022-01

Identifier Type: -

Identifier Source: org_study_id