Diet, Hepcidin, and Chemotherapy RDI

Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gynecologic Cancer; Ovarian Cancer; Fallopian Tube Cancer; Endometrial Cancer; Breast Cancer Female; Primary Peritoneal Carcinoma

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • George Washington University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July, 2024 - July, 2026

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum hepcidin concentration	ng/ml, continuous	pre-chemotherapy, single measure
Chemotherapy relative dose intensity	Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration	during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematologic toxicity	Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia)	at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment delays	Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms	at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment change or discontinuation	Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms	at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Blood transfusion	Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity	at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Hospitalizations	Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms	at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Kim Robien, PhD, RD, Milken Institute School of Public Health, George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: nutrition; anemia; inflammation; toxicity; chemotoxicity
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hematologic Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Uterine Neoplasms; Fallopian Tube Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Ovarian Neoplasms; Inflammation; Endometrial Neoplasms; Anemia; Fallopian Tube Neoplasms
• Other Study ID Numbers: NCR245680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Qualified researchers may contact the PI with proposals to collaborate on secondary analyses using the study data. To protect participants privacy and data security, no individual patient data will be made available to external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No