Diet, Hepcidin, and Chemotherapy RDI

George Washington University (GW)

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT06483997

NCR245680

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design