Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06376604 | RECRUITING | Cancer, Ovarian

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Sponsor:

L-none inc

Brief Summary:

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

Condition or disease

Cancer, Ovarian

Chemotherapy Effect

Calorie Deficiency

Fasting, Intermittent

Intervention/treatment

Fasting Mimicking Diet

Chemotherapy

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : NONE
Masking Description : Outcomes Assessor
Primary Purpose : SUPPORTIVE_CARE
Official Title : Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
Actual Study Start Date : 2021-09-08
Estimated Primary Completion Date : 2025-09-01
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Location Details

NCT06376604

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Tennessee

The University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920