Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

April 18, 2024 updated by: L-Nutra Inc

Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

Study Type

Interventional

Enrollment (Estimated)

30

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

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • The University of Tennessee Medical Center
        • 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:

  • Women
  • Age 35-70 years old (both inclusive)
  • Biopsy proven gynecologic malignancy
  • Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
  • BMI greater than or equal to 18.5
  • Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
  • Willing to adhere to a 5-day fasting mimicking diet

Exclusion Criteria:

  • Pregnant or nursing mothers
  • Prisoners
  • Patients with diabetes or history of hypoglycemia
  • Taking daily medications that cannot be safely taken without food
  • History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
  • Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
  • Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMD
In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
Other: Fasting Mimicking Diet
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.
Drug: Chemotherapy
6 cycles of standard chemotherapy for the gynecologic malignancy.
Active Comparator: Control
Subjects will receive the standard care and no dietary changes.
Drug: Chemotherapy
6 cycles of standard chemotherapy for the gynecologic malignancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
Time Frame: Week 0-21
The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.
Week 0-21
Rate of Adherence
Time Frame: Week 0-21
The ability to adhere to a 5-day fasting mimicking diet.
Week 0-21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Week 0, Week12, Week 21
Change in body weight.
Week 0, Week12, Week 21
Change in Body Composition
Time Frame: Week 0, Week12, Week 21
Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.
Week 0, Week12, Week 21
Change in HbA1c
Time Frame: Week 0, Week 21
Change in blood HbA1c.
Week 0, Week 21
Change in Insulin Like Growth Factor 1 (IGF-1) Concentration
Time Frame: Week 0, Week 21
Change in blood insulin like growth factor 1 level.
Week 0, Week 21
Change in Fasting Insulin Concentration
Time Frame: Week 0, Week 21
Change in fasting insulin level.
Week 0, Week 21
Change in Fasting Glucose Concentration
Time Frame: Week 0, Week 21
Change in fasting glucose level.
Week 0, Week 21
Change in High-sensitivity C reactive protein Concentration
Time Frame: Week 0, Week 21
Change in blood C reactive protein level.
Week 0, Week 21
Change in Leptin Concentration
Time Frame: Week 0, Week 21
Change in blood leptin level.
Week 0, Week 21
Change in planned chemotherapy regimen
Time Frame: Week 0-21
Deviation from the planned chemotherapy regimen.
Week 0-21
Number of Hospitalization Days
Time Frame: Week 0-21
Days of hospitalization
Week 0-21
Rate of Chemotherapy Side Effects
Time Frame: Week 0-21
Rate of Adverse effects associated with chemotherapy
Week 0-21

Collaborators and Investigators

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

Sponsor

L-Nutra Inc

Collaborators

University of Tennessee Medical Center

Investigators

  • Principal Investigator: Jonathan D Boone, The University of Tennessee Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 8, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNT55

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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