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

NCT05861362 | Completed

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change between baseline and final (average 5 weeks) TyG index

  Through study completion, an average of 5 weeks

Study Arms (1)

FAST

EXPERIMENTAL

5:2 intermittent fasting group

Radiation: Curative radiotherapy; Behavioral: 5:2 intermittent fasting

Interventions

Curative radiotherapy RADIATION

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

FAST

5:2 intermittent fasting BEHAVIORAL

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

FAST

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-metastasized breast cancer
• Indication for curative radiotherapy

You may not qualify if:

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

Sponsors & Collaborators

• MVZ Leopoldina GmbH: lead

Study Sites (2)

Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

Location

Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology

Schweinfurt, Bavaria, 97421, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rainer J Klement, Ph.D.

  Department of Radiation Oncology, Leopoldina Hospital Schweinfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)