Diet, Hepcidin, and Chemotherapy RDI

Last updated: September 30, 2024
Sponsor: George Washington University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Fallopian Tube Cancer

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT06483997
NCR245680
  • Ages > 21
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been diagnosed with invasive breast cancer, OR

  • Have been diagnosed with epithelial ovarian cancer, fallopian tube or primaryperitoneal cancer, OR

  • Have been diagnosed with endometrial cancer

  • Are chemotherapy-naïve

  • Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapyfollowing lumpectomy for breast cancer patients) or neoadjuvant/inductionchemotherapy for gynecological cancer at GW Cancer Center

Exclusion

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 weeksprior to initial testing

  • Women who are cognitively unable to provide a diet history for the month prior toassessment.

Study Design

Total Participants: 100
Study Start date:
August 16, 2024
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • George Washington University Cancer Center

    Washington, District of Columbia 20052
    United States

    Active - Recruiting

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