Diet, Hepcidin, and Chemotherapy RDI

NCT ID: NCT06483997

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2026-07-31

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 neo/adjuvant 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 demographic/food 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 patient's 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 objectives/aims 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.

Conditions

Breast Cancer Female; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Endometrial Cancer; Gynecologic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with invasive breast cancer, OR
• Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR
• Have been diagnosed with endometrial cancer
• Are chemotherapy-naïve
• Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapy following lumpectomy for breast cancer patients) or neoadjuvant/induction chemotherapy for gynecological cancer at GW Cancer Center

Exclusion Criteria

• Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia)
• Pregnant at the time of potential enrollment
• Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing
• Women who are cognitively unable to provide a diet history for the month prior to assessment.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Robien

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim Robien, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Milken Institute School of Public Health, George Washington University

Locations

George Washington University Cancer Center

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCR245680

Identifier Type: -

Identifier Source: org_study_id