Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483997
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Diet Hepcidin and Chemotherapy RDI
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Associations Between Diet Hepcidin and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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 prospective observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neoadjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations Associations between hepcidin concentration and relative dose intensity RDI of chemotherapy will also be evaluated
Detailed Description:
This is a prospective observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1 2024 - approximately September 2025 At study baseline after diagnosis but prior to starting chemotherapy participants will complete a 30-minute food frequency questionnaire FFQ and demographicfood security survey using a preprogrammed iPad in the clinic The clinical research nurse will obtain an additional research blood draw at the same time as the patients routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement Data on cancer type premorbid medical conditions and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days Data will be used to address the objectives below
Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment the objectivesaims of this study will be to
1 Determine the extent to which pretreatment self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
2 Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI
Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment the objectivesaims of this study will be to
1 Determine the extent to which pretreatment self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
2 Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI
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