Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia

April 7, 2024 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

The Effect of Fasting Mimicking Diet With Chemotherapy on the Number of Blasts and Platelets and Quality of Life in Patients With Acute Lymphoid Leukemia and Acute Myeloid Leukemia

The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19839-63113
        • Recruiting
        • Ehsan Hejazi
        • Contact:
    • Middle East
      • Tehran, Middle East, Iran, Islamic Republic of, 19835
        • Recruiting
        • Azita Hekmatdoost
        • 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

No

Description

Inclusion Criteria:

  • People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy

    • Willingness to cooperate
    • BMI >18.5

Exclusion Criteria:

  • diabetes
  • metastases to other organ
  • Unwillingness to continue the study by patients

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fasting mimicking diet
the intervention group that receive fasting mimicking diet with chemotherapy
Dietary supplement: fasting mimicking diet
Fasting mimicking diet is limited calorie diet to enhance the effectiveness of chemotherapy
No Intervention: control
the control group that receive chemotherapy without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blast cell count
Time Frame: at 4th week
the number of blast cell in perpheral blood
at 4th week
Quality of life
Time Frame: at the beginning and 4th week
Measuring the quality of life using EORTC QLQ questionnaire
at the beginning and 4th week

Collaborators and Investigators

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

Sponsor

National Nutrition and Food Technology Institute

Investigators

  • Principal Investigator: Ehsan Hejazi, PhD, Beheshti University of Medical Sciences

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 2, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nnftri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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