Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients

September 21, 2023 updated by: Odysseas Androutsos, University of Thessaly

Fasting Diet and Chemotherapy Toxicity

This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet of 60 hours (36h prior chemotherapy and 24h after the end of chemotherary), while the control group will follow regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet.

The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet for 60 hours (36h prior chemotherapy and 24h after the end of chemotherapy), while the control group will follow regular diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet. The patients will be randomized in the two groups. A total of 50 patients is required. Biochemical data, anthropometric measures and grading of toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of MedDietScore) will be assessed prior, during and after the intervention, in both groups. Nutritional counseling will be performed by Registered Dietitian, and telephone interviews will be used to record adherence to fasting diet and Mediterranean diet.

The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.

Study Type

Interventional

Enrollment (Estimated)

50

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

  • Greece
    • Thessaly
      • Tríkala, Thessaly, Greece, 42132
        • Recruiting
        • Department of Nutrition-Dietetics
        • Contact:
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • breast cancer patients with first diagnosis of breast cancer
  • no distinct metastasis
  • patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy

Exclusion Criteria:

  • BMI<19kg/m2
  • unintentional weight loss of >3 or >5 kg the last 3 or 6 months respectively
  • medical history of anorexia nervosa, boulimia or any other eating disorders
  • renal failure (creatinine >2mg/dl)
  • diabetes mellitus (type I or Insulin dependent type II)
  • serious psychiatric disease
  • serious cardiovascular disease
  • mobility limitations
  • being participant in any other 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
Other: fasting diet
A total of 50 patients with breast cancer will be randomly devided in intervention and control group. Intervention group will follow a 60 hours fasting diet (36h prior and 24h after chemotherapy infusion), low in calories, mainly plant based, and the Mediterranean Diet in the meantime between chemotherapy cycles. Control group will receive only standard of care. Nutritional counseling and dietary records will be performed by registered dietitian. Adherence to the Mediterranean Diet will be estimated with MedDietScore. Grade of toxicity will be estimated by using the National Cancer Institute Common Terminology Criteria for Adverse Events. All participants will be encourange to continue usual physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
Time Frame: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.
Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Data will be collected and comparison between the two groups will be performed after each chemotherapy cycle.
The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.

Collaborators and Investigators

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

Sponsor

University of Thessaly

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)

July 1, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fasting diet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Fasting, Diet, Chemotherapy, Toxicity

Clinical Trials on fasting diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe