Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386887
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-15
Brief Title:
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
The Feasibility Safety and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to see if timed fasting periods of time that you dont eat in participants who are receiving chemotherapy prior to surgery is achievable safe and can improve quality of life symptoms and outcomes results compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer The main questions it aims to answer are
Is it feasible to use intermittent fasting during neoadjuvant chemotherapy
Is it safe to use intermittent fasting during neoadjuvant chemotherapy
Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy
Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable safe and able to improve quality of life symptoms and outcomes
Participants will
Receive either the fasting intervention schedule of times when you do not eat or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy
All participants will be asked to complete chemotherapy and surgery cancer imaging baseline screening tests nutritional assessments food diaries blood tests and surveys about wellbeing
Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week
Is it feasible to use intermittent fasting during neoadjuvant chemotherapy
Is it safe to use intermittent fasting during neoadjuvant chemotherapy
Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy
Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable safe and able to improve quality of life symptoms and outcomes
Participants will
Receive either the fasting intervention schedule of times when you do not eat or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy
All participants will be asked to complete chemotherapy and surgery cancer imaging baseline screening tests nutritional assessments food diaries blood tests and surveys about wellbeing
Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week
Detailed Description:
The quality of diet can affect the biology of cancer For example evidence implies a high fat Western diet may impose adverse events on ovarian cancer outcomes and the potential that the gut microbiome alterations secondary to dietary changes may impact tumor responsiveness to treatment and outcomes This study seeks to clarify the effect of dietary intervention on the tumor and gut microbiome and ovarian cancer biology The objectives of this study include
Primary To test the feasibility and safety of IF during neoadjuvant chemotherapy including effects on body composition
Secondary To measure the effects of IF on participant reported outcomes chemotherapy toxicity and quality of life
Exploratory To test the effect of IF on pathologic response systemic inflammatory and immune responses microbial diversity and metabolic pathway alterations
Primary To test the feasibility and safety of IF during neoadjuvant chemotherapy including effects on body composition
Secondary To measure the effects of IF on participant reported outcomes chemotherapy toxicity and quality of life
Exploratory To test the effect of IF on pathologic response systemic inflammatory and immune responses microbial diversity and metabolic pathway alterations
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