Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376604
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Brief Title:
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Sponsor:
L-Nutra Inc
Organization:
L-Nutra Inc
Study Overview
Official Title:
Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None