Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06483997

Diet, Hepcidin, and Chemotherapy RDI

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Female Adnexal Diseases Anemia Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Gynecologic Cancer Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Peritoneal Carcinoma Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

George Washington University Cancer Center

Washington D.C., District of Columbia, 20052, United States

About this study

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:

  • 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
  • Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum hepcidin concentration

    Time frame: pre-chemotherapy, single measure

    ng/ml, continuous

  2. Chemotherapy relative dose intensity

    Time frame: during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures

    Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration

Secondary outcomes

  1. Hematologic toxicity

    Time frame: at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

    Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia)

  2. Treatment delays

    Time frame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

    Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms

  3. Treatment change or discontinuation

    Time frame: at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

    Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms

  4. Blood transfusion

    Time frame: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

    Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity

  5. Hospitalizations

    Time frame: at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)

    Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.