NCT06353698

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

February 26, 2024

Last Update Submit

April 7, 2024

Conditions

Fasting Mimicking DietLeukemia

Outcome Measures

Primary Outcomes (2)

  • Blast cell count

    the number of blast cell in perpheral blood

    at 4th week

  • Quality of life

    Measuring the quality of life using EORTC QLQ questionnaire

    at the beginning and 4th week

Study Arms (2)

fasting mimicking diet

EXPERIMENTAL

the intervention group that receive fasting mimicking diet with chemotherapy

Dietary Supplement: fasting mimicking diet

control

NO INTERVENTION

the control group that receive chemotherapy without any intervention

Interventions

fasting mimicking dietDIETARY_SUPPLEMENT

Fasting mimicking diet is limited calorie diet to enhance the effectiveness of chemotherapy

fasting mimicking diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy
  • Willingness to cooperate
  • BMI \>18.5

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

RECRUITING

Ehsan Hejazi

Tehran, 19839-63113, Iran

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ehsan Hejazi, PhD

    Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehsan Hejazi, PhD

CONTACT

00989121530775ehsanhejazi@gmail.com

Azita Hekmatdoost

CONTACT

009123065084a_hekmat2000@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 26, 2024

First Posted

April 9, 2024

Study Start

July 2, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)